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TETRIS is a multi-center, prospective observational cohort study. It will include participants with COPD who are on an existing combined treatment of long-acting muscarinic antagonist (LAMA), long-acting beta 2 agonists (LABA) and inhaled corticosteroids (ICS).
COPD is a disabling respiratory disease characterized by airflow obstruction and associated symptoms, including breathing difficulties caused by shortness of breath and wheezing, airway hyperactivity, chronic cough, sputum production, exercise intolerance, and poor quality of life. In accordance with the GOLD (Global Initiative for Chronic Obstructive Lung Disease) recommendations, it is important to assess the characteristics and treatment patterns of participants prior to triple therapy initiation, in order to determine adherence to these guidelines and understand how participants progress to triple therapy. Despite a clearly defined guidance from GOLD treatment recommendations for the initiation and maintenance of triple therapy, treatment changes in Germany, including de-escalation, are often seen in treatment reality. This study is intended to gain a better understanding of what influences the treatment decision of German physicians in primary and secondary care under real life conditions, to elicit the reasons for treatment changes and to describe long-term outcomes with participants initiated on triple therapy over a period of two years. This study will also describe the temporal dynamics of treatment pattern and to unravel potentially complex participant's journeys in different German regions and also to identify and follow-up a variety of 'treatable traits' in COPD participants, which when modified may lead to improved health outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with chronic obstructive pulmonary disease (COPD) | Participants with COPD, who will be treated with triple therapy (single inhaler triple therapy [SITT] or multiple inhaler triple therapy [MITT]) for at least 2 but not longer than 48 weeks will be enrolled in this study. No study treatment will be administered during conduct of this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prospective observational cohort study | Other | prospective observational cohort study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Continuously Received Triple Therapy for 6 Months | Percentage of participants who continuously received triple therapy (SITT or MITT) for 6 months from visit 1 (Day 1 of Month 1) have been presented. Percentage values are rounded-off. | From Day 1 (Month 1) up to 6 months |
| Percentage of Participants Who Continuously Received Triple Therapy for 12 Months | Percentage of participants who continuously received triple therapy (SITT or MITT) for 12 months from visit 1 (Day 1 of Month 1) have been presented. Percentage values are rounded-off. | From Day 1 (Month 1) up to 12 months |
| Percentage of Participants Who Continuously Received Triple Therapy for 24 Months | Percentage of participants who continuously received triple therapy (SITT or MITT) for 24 months from visit 1 (Day 1 of Month 1) have been presented. Percentage values are rounded-off. | From Day 1 (Month 1) up to 24 months |
| Time to Stop Triple Therapy | Time to stop triple therapy refers to the time duration from visit 1 at which a triple therapy (SITT or MITT) was safely and appropriately discontinued because its intended goals had been achieved, or no longer attainable, or risks outweighed the benefits. It was evaluated by Kaplan-Maier analysis. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Diagnosis of Asthma at the Age of <40 Years | Percentage of participants with diagnosis of asthma at the age of <40 years have been presented. Data was collected at Baseline visit on Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | Baseline (Day 1) |
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Inclusion Criteria:
Exclusion Criteria:
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This study plans to recruit participants with moderate to severe COPD who have been on triple therapy for at least 6 and for a maximum of 18 weeks.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Hanover | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41418889 | Derived | Rohde G, Vogelmeier CF, Beeh KM, Kardos P, Paulsson T, Watz H, Westermayer B, Mohan T, Noorduyn SG, Claussen J. TETRIS - Prospective study to observe clinical outcomes of triple therapy in COPD patients: Up to 12 months interim analysis. Respir Med. 2026 Jan;251:108597. doi: 10.1016/j.rmed.2025.108597. Epub 2025 Dec 17. | |
| 39436955 |
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Total of 1212 participants were enrolled in this study,however 1196 participants were included in full analysis set(FAS)(as 16 participants were enrolled with incomplete documentation).FAS included all participants who signed Informed Consent Form[ICF],met all inclusion criteria and none of the exclusion criteria, and completed visit1. As pre-specified in protocol and SAP, a combined analysis across all cohorts was performed. Cohorts were used for representative sampling, not separate analyses.
This was a non-interventional study, it did not include treatment interventions. Data was collected at participant's routine visits.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Chronic Obstructive Pulmonary Disease (COPD) | Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy [SITT] or multiple inhaler triple therapy [MITT]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Baseline Characteristic data are reported for the Full Analysis Set which consisted of all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Chronic Obstructive Pulmonary Disease (COPD) | Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy [SITT] or multiple inhaler triple therapy [MITT]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Continuously Received Triple Therapy for 6 Months | Percentage of participants who continuously received triple therapy (SITT or MITT) for 6 months from visit 1 (Day 1 of Month 1) have been presented. Percentage values are rounded-off. | Full Analysis Set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. | Posted | Number | Percentage of participants | From Day 1 (Month 1) up to 6 months |
|
All-cause mortality, non-serious drug-related adverse events and serious adverse events (SAEs) were collected up to 24 months
Only all-cause mortality, SAEs and non-serious drug-related adverse events were collected, but not all non-SAEs. Safety analysis set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. 16 participants from enrolled population were with incomplete documentation, hence were not included in Safety analysis set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Chronic Obstructive Pulmonary Disease (COPD) | Participants with COPD, who have already been treated with triple therapy (single inhaler triple therapy [SITT] or multiple inhaler triple therapy [MITT]) for at least 2 but not longer than 48 weeks were enrolled in this study. No study treatment was administered during conduct of this study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 16, 2022 | Jun 30, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 25, 2024 | Jun 30, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Percentage of Participants With Peripheral Blood Eosinophils (EOS) Count <100 Cells/uL, 100 to <200 Cells/uL, 200 to <300 Cells/uL and >=300 Cells/uL at Baseline |
Percentage of participants with peripheral blood EOS count less than (<) 100 cells per (/) micro liter (uL), 100 to <200 cells/uL, 200 to greater than (>) 300 cells/uL and greater than equal to (>=) 300 cells/uL have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. |
| Baseline (Day 1) |
| Percentage of Participants With a Physician's Diagnosis of COPD by Site Localization | Percentage of participants with a physician's diagnosis of COPD have been categorized according to the site localization i.e. East, North, South, and West Germany. Data was collected at Baseline visit on Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | Baseline (Day 1) |
| Percentage of Participants With a Physician's Diagnosis of COPD by Physicians Group | Percentage of participants with a physician's diagnosis of COPD categorized by pneumologists and general practitioners have been presented. Data was collected at Baseline visit on Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | Baseline (Day 1) |
| Percentage of Participants With COPD Symptom and Risk Classes (GOLD 1 to 4) at Baseline | COPD was classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. Participants were classified based on symptom and risk of exacerbation, where GOLD 1 (mild COPD), GOLD 2 (moderate COPD), GOLD 3 (severe COPD) and GOLD 4 (very severe COPD). Data for percentage of participants with COPD symptom and risk classes (GOLD 1, GOLD 2, GOLD 3, and GOLD 4) have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | Baseline (Day 1) |
| Percentage of Participants With COPD Symptom and Risk Classes (GOLD A to D) at Baseline | COPD was classified using the GOLD criteria. Participants are classified based on symptoms and risk of exacerbation, where GOLD A=Few symptoms low risk, GOLD B= More symptoms low risk, GOLD C= Few symptoms high risk and GOLD D= More symptoms high risk. Data for percentage of participants with COPD symptom and risk classes (GOLD A, GOLD B, GOLD C, and GOLD D) have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | Baseline (Day 1) |
| Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24 | Percentage of participants with non-missing concomitant respiratory medication received during the study are presented. Percentage of participants were categorized by the substance class of concomitant respiratory medication received by them which included oral glucocorticosteroids, leukotriene receptor antagonist, oral betamimetics, immunotherapy, antibiotics for respiratory indications, and other substances with cardiac or respiratory effects. Percentage values are rounded-off. | At Months 6, 12 and 24 |
| Percentage of Participants by Their Duration of Triple Therapy Before Study Start | Data for percentage of participants by their duration of triple therapy before study start have been presented. Data was categorized into following categories according to duration of triple therapy they received prior to study start: <3 months, 3 to <6 months, >=6 months. Percentage values are rounded-off. | Up to 48 weeks before study start (Day 1 of Month 1) |
| Percentage of Participants by Their Smoking Status at Months 6, 12 and 24 | Percentage of participants were categorized by their smoking status as Lifelong non-smoker, Current smoker and Previous smoker. Percentage values are rounded-off. | At Months 6, 12 and 24 |
| Percentage of Participants With a Lifelong Non-smoking History at Baseline | Percentage of participants with a lifelong non-smoking history at Baseline have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | At Baseline (Day 1) |
| Percentage of Participants With Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) Ratio (FEV1/FVC) of <0.7 at Study Enrollment and at 6, 12 and 24 Months | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is a measure of lung function and is defined as total amount of air that can be exhaled after taking a deep breath. FEV1 and FVC was measured using spirometry. FEV1/FVC ratio was calculated as FEV1/FVC ratio=FEV1/FVC*100. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage of participants with FEV1/FVC value <0.7 have been presented. Percentage values are rounded-off. | Baseline (Day 1), Months 6, 12, and 24 |
| Percentage of Participants With Any Moderate/Severe Exacerbation in the 24 Months Prior to Baseline or 3 Months Prior to Each Subsequent On-study Visits at Months 6, 12 and 24 | Moderate exacerbations are defined as COPD exacerbations that require either systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as those requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage of participants with any moderate/severe exacerbation in the 24 months prior to Baseline or 3 months prior to each subsequent on-study visits at Months 6, 12 and 24 have been presented. Percentage values are rounded-off. | Up to 24 months prior to Baseline (Day 1); Up to 3 months prior to Month 6; Up to 3 months prior to Month 12; Up to 3 months prior to Month 24 |
| Percentage of Participants With a COPD Assessment Test (CAT) Score <=10, 11-19, >=20 at Baseline and at 6, 12 and 24 Months Documentation | The CAT is a validated measure of health status in COPD. The CAT is an 8-item, patient-completed instrument that covers symptoms such as cough, phlegm, chest tightness, breathlessness, and disease impacts including physical activity, confidence, sleep and energy. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A CAT sum score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. CAT sum score interpreted as <=10: low impact level, 11-19: Medium impact level, >=20: high impact level. Data for percentage of participants with CAT sum score of <=10, 11-19, and >=20 have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | Baseline (Day 1), Months 6, 12, and 24 |
| Percentage of Participants With Peripheral Blood EOS Count of <300 and >=300 Cells/uL at 6, 12 and 24 Months | Percentage of participants with peripheral blood EOS count of <300 cells/uL and >=300 cells/uL have been presented. Percentage values are rounded-off. | At Months 6, 12, and 24 |
| Percentage of Participants With Chronic Bronchitis Phenotype | Chronic bronchitis phenotype is one of the 'treatable traits' in COPD participants, which - when modified - might lead to improved health outcomes. Percentage of participants with chronic bronchitis phenotype have been presented. Percentage values are rounded-off. | Up to 24 months |
| Percentage of Participants With at Least One Switch From Triple Therapy to Long-acting Muscarinic Antagonist (LAMA)/Long-acting Beta Agonist (LABA) From Months 6 to 24 | Percentage of participants with at least one switch from triple therapy to LAMA/LABA from Months 6 to 24 have been presented. Percentage values are rounded-off. | Months 6 to 24 |
| Percentage of Participants With at Least One Switch From Triple Therapy to Inhaled Corticosteroids (ICS)/LABA From Months 6 to 24 | Percentage of participants with at least one switch from triple therapy to ICS/LABA from Months 6 to 24 have been presented. Percentage values are rounded-off. | Months 6 to 24 |
| Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group | Percentage of participants with reasons to start COPD triple therapy in overall participants group have been presented. Reasons to start COPD triple therapy were documented in medical records by physicians. These reasons have been presented in separate categories. Also, data has been presented by type of physician (general practitioners [GP] and pneumologists) who documented these reasons. Percentage values are rounded-off. | Up to 24 months |
| Percentage of Participants With Change From Triple to Dual Therapy and Back to Triple Therapy (at Least One Re-escalation) During a 24-month Observation Period After Study Enrollment (Split by SITT and MITT) | Percentage of participants with change from triple to dual therapy and back to triple therapy (re-escalation) during a 24-month observation period after study enrollment have been presented. Data has been presented in categories split by the type of triple therapy (SITT and MITT) initiated by participants prior to change. Percentage values are rounded-off. | Up to 24 months |
| Percentage of Participants With Change From Triple to Dual Therapy and Back to Triple Therapy (at Least One Re-escalation) During a 24-month Observation Period After Study Enrollment (Split by LAMA/LABA, ICS/LABA and ICS/LAMA) | Percentage of participants with change from triple to dual therapy and back to triple therapy (at least one re-escalation) during a 24-month observation period after study enrollment have been presented. Data has been presented in categories split by the type of dual therapy (LAMA/LABA, ICS/LABA and ICS/LAMA) received by participant after change from triple therapy. Percentage values are rounded-off. | Up to 24 months |
| Percentage of Participants With at Least One Change From MITT to SITT or SITT to MITT During a 24-month Observation Period | Percentage of participants with at least one change in their triple therapy from MITT to SITT or SITT to MITT during a 24-month observation period have been presented. Percentage values are rounded-off. | Up to 24 months |
| Percentage of Participants With at Least One Change From SITT to SITT or MITT to MITT During a 24-month Observation Period | Percentage of participants with at least one change within their type of triple therapy - from SITT to SITT or MITT to MITT during a 24-month observation period have been presented. Percentage values are rounded-off. | Up to 24 months |
| Percentage of Participants With Change From Once Daily to Twice Daily or Twice Daily to Once Daily Medication | Percentage of participants with change from once daily to twice daily or twice daily to once daily medication has been presented. Percentage values are rounded-off. | Up to 24 months |
| Percentage of Participants With a Change Between Different Inhaler Types | Percentage of participants with a change between different inhaler types have been presented. Percentage values are rounded-off. | Up to 24 months |
| Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group | Percentage of participants with prespecified reasons to change a triple therapy (TT) (either MITT or SITT) by type of physician group have been presented. Reasons to change a triple therapy were documented in medical records by physicians. These reasons are included in separate categories. Also, data has been presented by type of physician (general practitioners [GP] and pneumologists). Percentage values are rounded-off. | Up to 24 months |
| Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants | Percentage of participants with reasons for change in their triple therapy to another triple therapy in overall participants group have been presented. Reasons for change in triple therapy to another triple therapy were documented in medical records by physician. These reasons are included in separate categories. Percentage values are rounded-off. | Up to 24 months |
| Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation | Percentage of participants with reasons for change from triple therapy to therapy de-escalation in overall participants group have been presented. A participant was classified as de-escalation, if there was at least one change from triple therapy to a therapy with just two components within the first 365 days of observation. Reasons for change from triple therapy to therapy de-escalation were documented in medical records by physicians. These reasons are included in separate categories. Percentage values are rounded-off. | Up to 24 months |
| Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy | Percentage of participants with reasons to change de-escalated therapy back to triple therapy in overall participants group have been presented. A participant was classified as de-escalation, if there was at least one change from triple therapy to a therapy with just two components within the first 365 days of observation. Reasons to change de-escalated therapy back to triple therapy were documented in medical records by physicians. These reasons are included in separate categories. Percentage values are rounded-off. | Up to 24 months |
| Mean Annual Rate of Moderate and/or Severe Exacerbations in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History | The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the study period (per participant per year) was assessed. Annualized rate of moderate and severe exacerbations was calculated as Annual exacerbation rate = total number of moderate or severe exacerbation/total person years. Moderate exacerbations are defined as COPD exacerbations that require either systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as those requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. Data for mean annual rate of moderate and/or severe exacerbations is presented for overall participants, and by their peripheral EOS count (missing, <300 and >=300 cells/uL), smoking status (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown). | Up to 24 months |
| Mean Annual Rate of Hospitalizations Due to Severe Exacerbations | Severe exacerbations are defined as those requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. Annualized rate of hospitalization due to severe exacerbations was calculated as Annual hospitalization rate equal to (=) number of hospitalizations due to severe exacerbations divided by (/) total person years. | Up to 24 months |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6 | FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 6 minus the value at Baseline. Data for change from Baseline in FEV1 is presented for overall participants, and by their peripheral blood eosinophil count (missing, <300 and >=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown). | Baseline (Day 1) and at Month 6 |
| Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12 | FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 12 minus the value at Baseline. Data for change from Baseline in FEV1 is presented for overall participants, and by their peripheral blood eosinophil count (missing, <300 and >=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown). | Baseline (Day 1) and at Month 12 |
| Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24 | FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 24 minus the value at Baseline. Data for change from Baseline in FEV1 is presented for overall participants, and by their peripheral blood eosinophil count (missing, <300 and >=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown). | Baseline (Day 1) and at Month 24 |
| Change From Baseline in Forced Vital Capacity (FVC) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6 | FVC is a measure of lung function and is defined as total amount of air that can be exhaled after taking a deep breath. FVC was measured using spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 6 minus the value at Baseline. Data for change from Baseline in FVC is presented for overall participants, and by their peripheral blood eosinophil count (missing, <300 and >=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown). | Baseline (Day 1) and at Month 6 |
| Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12 | FVC is a measure of lung function and is defined as total amount of air that can be exhaled after taking a deep breath. FVC was measured using spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 12 minus the value at Baseline. Data for change from Baseline in FVC is presented for overall participants, and by their peripheral blood eosinophil count (missing, <300 and >=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown). | Baseline (Day 1) and at Month 12 |
| Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24 | FVC is a measure of lung function and is defined as total amount of air that can be exhaled after taking a deep breath. FVC was measured using spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 24 minus the value at Baseline. Data for change from Baseline in FVC is presented for overall participants, and by their peripheral blood eosinophil count (missing, <300 and >=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown). | Baseline (Day 1) and at Month 24 |
| Percentage of Participants With Change in COPD Symptoms at Months 6, 12 and 24 From Baseline | Change in COPD symptoms were evaluated through COPD Assessment Test (CAT) and were categorized as stable symptoms, less symptoms, and more symptoms by comparing with Baseline. Percentage of participants with change in COPD symptoms at Months 6, 12 and 24 from Baseline have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | Baseline (Day 1), Months 6, 12 and 24 |
| Change From Baseline in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Months 12 and 24 | EQ-5D-5L is self-assessment questionnaire,consisting of 5 items covering 5 dimensions (mobility,self care,usual activities,pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health state). Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the post-dose visit value minus Baseline value. | Baseline (Day 1), Months 12 and 24 |
| Percentage of Participants Experiencing a Clinically Important Deterioration | Clinically important deterioration was defined as if at least one of the following conditions exists at any point of time during the observational period: decrease (>=100 milliliter [mL]) of FEV1 from Baseline (missing values are treated as no decrease); increase (>2 units) of CAT from Baseline (missing values are treated as no increase); any documented exacerbation; and all-cause mortality. Percentage of participants experiencing a clinically important deterioration during 24 months observation period have been presented. Percentage values are rounded-off. | Up to 24 months |
| Time to First Moderate or Severe Exacerbation | The time to first moderate or severe exacerbation was defined as the duration between onset of first moderate or severe acute exacerbation of COPD from Day 1. Moderate exacerbations are defined as COPD exacerbations that require either systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as those requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. It was evaluated by Kaplan-Maier analysis. | Up to 24 months |
| Time to First Hospitalization | Time to first hospitalization is calculated as the time interval between date of study enrollment (Day 1) and the date of the first hospital admission for a relevant cause. Time to first hospitalization was analyzed using Kaplan-Meier methods. | Up to 24 months |
| Time to Death | Time to death is calculated as the duration between date of study enrollment (Day 1) and the date of death of a participant. Time to death was analyzed using Kaplan-Meier methods. | Up to 24 months |
| Number of COPD Related Visits | Number of COPD related visits made by participants have been presented and categorized by type of physician (general practitioners and pneumologists). | Up to 24 months |
| Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Physician | The annual rate of exacerbations during the observation period (per participant per year) was assessed. Annualized rate of exacerbations was calculated as Annual exacerbation rate = total number of exacerbation/total person years. Data for mean annual rate of exacerbations categorized by general practitioners and pneumologists have been presented. | Up to 24 months |
| Mean Annual Rate of Hospitalization Due to Severe Exacerbation Over a 24-month Observation Period Categorized by Physician | Annualized rate of hospitalization due to severe exacerbations was calculated as Annual hospitalization rate=number of hospitalizations due to severe exacerbations/total person years. Severe exacerbations are defined as COPD exacerbations requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. Data for mean annual rate of hospitalization due to severe exacerbation categorized by general practitioners and pneumologists have been presented. | Up to 24 months |
| Percentage of Participants Categorized by the Site Localization of Physician and by Type of Physician | Percentage of participants have been categorized according to the site localization (East, North, South, and West Germany) of physician and type of physician (general practitioners and pneumologists). Percentage values are rounded-off. | Up to 24 months |
| Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History | The annual rate of exacerbations during the observation period (per participant per year) was assessed. Annualized rate of exacerbations was calculated as Annual exacerbation rate = total number of exacerbation/total person years. Data for mean annual rate of exacerbations is presented by smoking status (Lifelong non-smoker, Current and previous smoker), peripheral blood eosinophil count (missing, <300 and >=300 cells/uL), and asthma history (missing, yes, no and unknown). Data was also categorized by the type of physician (general practitioners and pneumologists). | Up to 24 months |
| Number of Participants Who Had Pneumonia and Cardiovascular Events | Number of participants who had pneumonia and cardiovascular events have been presented. | Up to 24 months |
| Number Needed to Treat for Benefit (NNTB) for SITT Participants Compared to Non SITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events | NNTB is a metric used to assess the benefit of treatment. It indicates how many participants need to be treated to achieve one additional beneficial outcome with respect to exacerbations, pneumonia, and cardiovascular events. NNTB is presented as number of participants and is presented at Days 90 and 365 for participants on SIIT compared to non SITT. A participant is classified as SITT, if the treatment is SITT continuously for the first 365 days of observation. | Days 90 and 365 |
| Number Needed to Treat for Benefit (NNTB) for MITT Participants Compared to Non MITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events | NNTB is a metric used to assess the benefit of treatment. It indicates how many participants need to be treated to achieve one additional beneficial outcome with respect to exacerbations, pneumonia, and cardiovascular events. NNTB is presented as number of participants and is presented at Days 90 and 365 for participants on MITT compared to non MITT. A participant is classified as MITT, if the treatment is MITT continuously for the first 365 days of observation. | Days 90 and 365 |
| Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants Whose Triple Therapies Interrupted by ICS and/or LAMA "Off/on" Periods Compared to Other Triple Therapies | NNTB is a metric used to assess the benefit of treatment. It indicates how many participants need to be treated to achieve one additional beneficial outcome with respect to exacerbations, pneumonia, and cardiovascular events. NNTB is presented as number of participants and is presented at Days 90 and 365 for participants whose triple therapies were interrupted by ICS and/or LAMA "off/on" periods compared to other triple therapies. | Days 90 and 365 |
| Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants With Switch of Triple Therapies Between SITT and MITT Compared to no Switch | NNTB is a metric used to assess the benefit of treatment. It indicates how many participants need to be treated to achieve one additional beneficial outcome with respect to exacerbations, pneumonia, and cardiovascular events. NNTB is presented as number of participants and is presented at Days 90 and 365 for participants whose triple therapies were switched between SITT and MITT compared to no switch. A participants is classified as switch, if there is no de-escalation of therapy, but at least one switch between SITT and MITT within the first 365 days of observation. | Days 90 and 365 |
| Vogelmeier CF, Beeh KM, Kardos P, Paulsson T, Rohde G, Watz H, Compton C, Mohan T, Claussen J. Baseline patient demographics for TETRIS: a prospective, noninterventional study to characterize the use of triple therapy for COPD in Germany. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241287621. doi: 10.1177/17534666241287621. |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Primary | Percentage of Participants Who Continuously Received Triple Therapy for 12 Months | Percentage of participants who continuously received triple therapy (SITT or MITT) for 12 months from visit 1 (Day 1 of Month 1) have been presented. Percentage values are rounded-off. | Full Analysis Set. | Posted | Number | Percentage of participants | From Day 1 (Month 1) up to 12 months |
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| Primary | Percentage of Participants Who Continuously Received Triple Therapy for 24 Months | Percentage of participants who continuously received triple therapy (SITT or MITT) for 24 months from visit 1 (Day 1 of Month 1) have been presented. Percentage values are rounded-off. | Full Analysis Set. | Posted | Number | Percentage of participants | From Day 1 (Month 1) up to 24 months |
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| Primary | Time to Stop Triple Therapy | Time to stop triple therapy refers to the time duration from visit 1 at which a triple therapy (SITT or MITT) was safely and appropriately discontinued because its intended goals had been achieved, or no longer attainable, or risks outweighed the benefits. It was evaluated by Kaplan-Maier analysis. | Full Analysis Set. | Posted | Median | Inter-Quartile Range | Days | Up to 24 months |
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| Secondary | Percentage of Participants With Diagnosis of Asthma at the Age of <40 Years | Percentage of participants with diagnosis of asthma at the age of <40 years have been presented. Data was collected at Baseline visit on Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Number | Percentage of participants | Baseline (Day 1) |
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| Secondary | Percentage of Participants With Peripheral Blood Eosinophils (EOS) Count <100 Cells/uL, 100 to <200 Cells/uL, 200 to <300 Cells/uL and >=300 Cells/uL at Baseline | Percentage of participants with peripheral blood EOS count less than (<) 100 cells per (/) micro liter (uL), 100 to <200 cells/uL, 200 to greater than (>) 300 cells/uL and greater than equal to (>=) 300 cells/uL have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Number | Percentage of participants | Baseline (Day 1) |
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| Secondary | Percentage of Participants With a Physician's Diagnosis of COPD by Site Localization | Percentage of participants with a physician's diagnosis of COPD have been categorized according to the site localization i.e. East, North, South, and West Germany. Data was collected at Baseline visit on Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | Full Analysis Set | Posted | Number | Percentage of participants | Baseline (Day 1) |
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| Secondary | Percentage of Participants With a Physician's Diagnosis of COPD by Physicians Group | Percentage of participants with a physician's diagnosis of COPD categorized by pneumologists and general practitioners have been presented. Data was collected at Baseline visit on Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Number | Percentage of participants | Baseline (Day 1) |
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| Secondary | Percentage of Participants With COPD Symptom and Risk Classes (GOLD 1 to 4) at Baseline | COPD was classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. Participants were classified based on symptom and risk of exacerbation, where GOLD 1 (mild COPD), GOLD 2 (moderate COPD), GOLD 3 (severe COPD) and GOLD 4 (very severe COPD). Data for percentage of participants with COPD symptom and risk classes (GOLD 1, GOLD 2, GOLD 3, and GOLD 4) have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | Full Analysis Set | Posted | Number | Percentage of participants | Baseline (Day 1) |
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| Secondary | Percentage of Participants With COPD Symptom and Risk Classes (GOLD A to D) at Baseline | COPD was classified using the GOLD criteria. Participants are classified based on symptoms and risk of exacerbation, where GOLD A=Few symptoms low risk, GOLD B= More symptoms low risk, GOLD C= Few symptoms high risk and GOLD D= More symptoms high risk. Data for percentage of participants with COPD symptom and risk classes (GOLD A, GOLD B, GOLD C, and GOLD D) have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | Full Analysis Set | Posted | Number | Percentage of participants | Baseline (Day 1) |
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| Secondary | Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24 | Percentage of participants with non-missing concomitant respiratory medication received during the study are presented. Percentage of participants were categorized by the substance class of concomitant respiratory medication received by them which included oral glucocorticosteroids, leukotriene receptor antagonist, oral betamimetics, immunotherapy, antibiotics for respiratory indications, and other substances with cardiac or respiratory effects. Percentage values are rounded-off. | Full Analysis Set. Participants may have provided multiple answers for this question, hence may have contributed to more than one category. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Number | Percentage of participants | At Months 6, 12 and 24 |
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| Secondary | Percentage of Participants by Their Duration of Triple Therapy Before Study Start | Data for percentage of participants by their duration of triple therapy before study start have been presented. Data was categorized into following categories according to duration of triple therapy they received prior to study start: <3 months, 3 to <6 months, >=6 months. Percentage values are rounded-off. | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Number | Percentage of participants | Up to 48 weeks before study start (Day 1 of Month 1) |
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| Secondary | Percentage of Participants by Their Smoking Status at Months 6, 12 and 24 | Percentage of participants were categorized by their smoking status as Lifelong non-smoker, Current smoker and Previous smoker. Percentage values are rounded-off. | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Number | Percentage of participants | At Months 6, 12 and 24 |
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| Secondary | Percentage of Participants With a Lifelong Non-smoking History at Baseline | Percentage of participants with a lifelong non-smoking history at Baseline have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | Full Analysis Set | Posted | Number | Percentage of participants | At Baseline (Day 1) |
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| Secondary | Percentage of Participants With Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) Ratio (FEV1/FVC) of <0.7 at Study Enrollment and at 6, 12 and 24 Months | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is a measure of lung function and is defined as total amount of air that can be exhaled after taking a deep breath. FEV1 and FVC was measured using spirometry. FEV1/FVC ratio was calculated as FEV1/FVC ratio=FEV1/FVC*100. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage of participants with FEV1/FVC value <0.7 have been presented. Percentage values are rounded-off. | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Number | Percentage of participants | Baseline (Day 1), Months 6, 12, and 24 |
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| Secondary | Percentage of Participants With Any Moderate/Severe Exacerbation in the 24 Months Prior to Baseline or 3 Months Prior to Each Subsequent On-study Visits at Months 6, 12 and 24 | Moderate exacerbations are defined as COPD exacerbations that require either systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as those requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage of participants with any moderate/severe exacerbation in the 24 months prior to Baseline or 3 months prior to each subsequent on-study visits at Months 6, 12 and 24 have been presented. Percentage values are rounded-off. | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Number | Percentage of participants | Up to 24 months prior to Baseline (Day 1); Up to 3 months prior to Month 6; Up to 3 months prior to Month 12; Up to 3 months prior to Month 24 |
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| Secondary | Percentage of Participants With a COPD Assessment Test (CAT) Score <=10, 11-19, >=20 at Baseline and at 6, 12 and 24 Months Documentation | The CAT is a validated measure of health status in COPD. The CAT is an 8-item, patient-completed instrument that covers symptoms such as cough, phlegm, chest tightness, breathlessness, and disease impacts including physical activity, confidence, sleep and energy. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A CAT sum score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. CAT sum score interpreted as <=10: low impact level, 11-19: Medium impact level, >=20: high impact level. Data for percentage of participants with CAT sum score of <=10, 11-19, and >=20 have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Number | Percentage of participants | Baseline (Day 1), Months 6, 12, and 24 |
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| Secondary | Percentage of Participants With Peripheral Blood EOS Count of <300 and >=300 Cells/uL at 6, 12 and 24 Months | Percentage of participants with peripheral blood EOS count of <300 cells/uL and >=300 cells/uL have been presented. Percentage values are rounded-off. | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Number | Percentage of participants | At Months 6, 12, and 24 |
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| Secondary | Percentage of Participants With Chronic Bronchitis Phenotype | Chronic bronchitis phenotype is one of the 'treatable traits' in COPD participants, which - when modified - might lead to improved health outcomes. Percentage of participants with chronic bronchitis phenotype have been presented. Percentage values are rounded-off. | Full Analysis Set | Posted | Number | Percentage of participants | Up to 24 months |
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| Secondary | Percentage of Participants With at Least One Switch From Triple Therapy to Long-acting Muscarinic Antagonist (LAMA)/Long-acting Beta Agonist (LABA) From Months 6 to 24 | Percentage of participants with at least one switch from triple therapy to LAMA/LABA from Months 6 to 24 have been presented. Percentage values are rounded-off. | Full Analysis Set | Posted | Number | Percentage of participants | Months 6 to 24 |
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| Secondary | Percentage of Participants With at Least One Switch From Triple Therapy to Inhaled Corticosteroids (ICS)/LABA From Months 6 to 24 | Percentage of participants with at least one switch from triple therapy to ICS/LABA from Months 6 to 24 have been presented. Percentage values are rounded-off. | Full Analysis Set | Posted | Number | Percentage of participants | Months 6 to 24 |
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| Secondary | Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group | Percentage of participants with reasons to start COPD triple therapy in overall participants group have been presented. Reasons to start COPD triple therapy were documented in medical records by physicians. These reasons have been presented in separate categories. Also, data has been presented by type of physician (general practitioners [GP] and pneumologists) who documented these reasons. Percentage values are rounded-off. | Full Analysis Set. A participant may have >1 reason to start triple therapy, hence total percentage of participants from different categories (reasons) may not yield 100%. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Number | Percentage of participants | Up to 24 months |
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| Secondary | Percentage of Participants With Change From Triple to Dual Therapy and Back to Triple Therapy (at Least One Re-escalation) During a 24-month Observation Period After Study Enrollment (Split by SITT and MITT) | Percentage of participants with change from triple to dual therapy and back to triple therapy (re-escalation) during a 24-month observation period after study enrollment have been presented. Data has been presented in categories split by the type of triple therapy (SITT and MITT) initiated by participants prior to change. Percentage values are rounded-off. | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Number | Percentage of participants | Up to 24 months |
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| Secondary | Percentage of Participants With Change From Triple to Dual Therapy and Back to Triple Therapy (at Least One Re-escalation) During a 24-month Observation Period After Study Enrollment (Split by LAMA/LABA, ICS/LABA and ICS/LAMA) | Percentage of participants with change from triple to dual therapy and back to triple therapy (at least one re-escalation) during a 24-month observation period after study enrollment have been presented. Data has been presented in categories split by the type of dual therapy (LAMA/LABA, ICS/LABA and ICS/LAMA) received by participant after change from triple therapy. Percentage values are rounded-off. | Full Analysis Set | Posted | Number | Percentage of participants | Up to 24 months |
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| Secondary | Percentage of Participants With at Least One Change From MITT to SITT or SITT to MITT During a 24-month Observation Period | Percentage of participants with at least one change in their triple therapy from MITT to SITT or SITT to MITT during a 24-month observation period have been presented. Percentage values are rounded-off. | Full Analysis Set | Posted | Number | Percentage of participants | Up to 24 months |
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| Secondary | Percentage of Participants With at Least One Change From SITT to SITT or MITT to MITT During a 24-month Observation Period | Percentage of participants with at least one change within their type of triple therapy - from SITT to SITT or MITT to MITT during a 24-month observation period have been presented. Percentage values are rounded-off. | Full Analysis Set | Posted | Number | Percentage of participants | Up to 24 months |
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| Secondary | Percentage of Participants With Change From Once Daily to Twice Daily or Twice Daily to Once Daily Medication | Percentage of participants with change from once daily to twice daily or twice daily to once daily medication has been presented. Percentage values are rounded-off. | Full Analysis Set | Posted | Number | Percentage of participants | Up to 24 months |
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| Secondary | Percentage of Participants With a Change Between Different Inhaler Types | Percentage of participants with a change between different inhaler types have been presented. Percentage values are rounded-off. | Full Analysis Set | Posted | Number | Percentage of participants | Up to 24 months |
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| Secondary | Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group | Percentage of participants with prespecified reasons to change a triple therapy (TT) (either MITT or SITT) by type of physician group have been presented. Reasons to change a triple therapy were documented in medical records by physicians. These reasons are included in separate categories. Also, data has been presented by type of physician (general practitioners [GP] and pneumologists). Percentage values are rounded-off. | Full Analysis Set. A participant may have >1 reason, hence total percentage of participants from different categories (reasons) may not yield 100%. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Number | Percentage of participants | Up to 24 months |
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| Secondary | Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants | Percentage of participants with reasons for change in their triple therapy to another triple therapy in overall participants group have been presented. Reasons for change in triple therapy to another triple therapy were documented in medical records by physician. These reasons are included in separate categories. Percentage values are rounded-off. | Full Analysis Set. A participant may have >1 reason, hence total percentage of participants from different categories (reasons) may not yield 100%. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Number | Percentage of participants | Up to 24 months |
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| Secondary | Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation | Percentage of participants with reasons for change from triple therapy to therapy de-escalation in overall participants group have been presented. A participant was classified as de-escalation, if there was at least one change from triple therapy to a therapy with just two components within the first 365 days of observation. Reasons for change from triple therapy to therapy de-escalation were documented in medical records by physicians. These reasons are included in separate categories. Percentage values are rounded-off. | Full Analysis Set. A participant may have >1 reason, hence total percentage of participants from different categories (reasons) may not yield 100%. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Number | Percentage of participants | Up to 24 months |
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| Secondary | Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy | Percentage of participants with reasons to change de-escalated therapy back to triple therapy in overall participants group have been presented. A participant was classified as de-escalation, if there was at least one change from triple therapy to a therapy with just two components within the first 365 days of observation. Reasons to change de-escalated therapy back to triple therapy were documented in medical records by physicians. These reasons are included in separate categories. Percentage values are rounded-off. | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Number | Percentage of participants | Up to 24 months |
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| Secondary | Mean Annual Rate of Moderate and/or Severe Exacerbations in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History | The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the study period (per participant per year) was assessed. Annualized rate of moderate and severe exacerbations was calculated as Annual exacerbation rate = total number of moderate or severe exacerbation/total person years. Moderate exacerbations are defined as COPD exacerbations that require either systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as those requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. Data for mean annual rate of moderate and/or severe exacerbations is presented for overall participants, and by their peripheral EOS count (missing, <300 and >=300 cells/uL), smoking status (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown). | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Exacerbations per participant per year | Up to 24 months |
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| Secondary | Mean Annual Rate of Hospitalizations Due to Severe Exacerbations | Severe exacerbations are defined as those requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. Annualized rate of hospitalization due to severe exacerbations was calculated as Annual hospitalization rate equal to (=) number of hospitalizations due to severe exacerbations divided by (/) total person years. | Full Analysis Set | Posted | Mean | Standard Deviation | Hospitalization per participant per year | Up to 24 months |
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| Secondary | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6 | FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 6 minus the value at Baseline. Data for change from Baseline in FEV1 is presented for overall participants, and by their peripheral blood eosinophil count (missing, <300 and >=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown). | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Liter | Baseline (Day 1) and at Month 6 |
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| Secondary | Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12 | FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 12 minus the value at Baseline. Data for change from Baseline in FEV1 is presented for overall participants, and by their peripheral blood eosinophil count (missing, <300 and >=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown). | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Liter | Baseline (Day 1) and at Month 12 |
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| Secondary | Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24 | FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 24 minus the value at Baseline. Data for change from Baseline in FEV1 is presented for overall participants, and by their peripheral blood eosinophil count (missing, <300 and >=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown). | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Liter | Baseline (Day 1) and at Month 24 |
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| Secondary | Change From Baseline in Forced Vital Capacity (FVC) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6 | FVC is a measure of lung function and is defined as total amount of air that can be exhaled after taking a deep breath. FVC was measured using spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 6 minus the value at Baseline. Data for change from Baseline in FVC is presented for overall participants, and by their peripheral blood eosinophil count (missing, <300 and >=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown). | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Liter | Baseline (Day 1) and at Month 6 |
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| Secondary | Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12 | FVC is a measure of lung function and is defined as total amount of air that can be exhaled after taking a deep breath. FVC was measured using spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 12 minus the value at Baseline. Data for change from Baseline in FVC is presented for overall participants, and by their peripheral blood eosinophil count (missing, <300 and >=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown). | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Liter | Baseline (Day 1) and at Month 12 |
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| Secondary | Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24 | FVC is a measure of lung function and is defined as total amount of air that can be exhaled after taking a deep breath. FVC was measured using spirometry. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the value at Month 24 minus the value at Baseline. Data for change from Baseline in FVC is presented for overall participants, and by their peripheral blood eosinophil count (missing, <300 and >=300 cells/uL), smoking history (Lifelong non-smoker, Current and previous smoker) and asthma history (missing, yes, no and unknown). | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Liter | Baseline (Day 1) and at Month 24 |
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| Secondary | Percentage of Participants With Change in COPD Symptoms at Months 6, 12 and 24 From Baseline | Change in COPD symptoms were evaluated through COPD Assessment Test (CAT) and were categorized as stable symptoms, less symptoms, and more symptoms by comparing with Baseline. Percentage of participants with change in COPD symptoms at Months 6, 12 and 24 from Baseline have been presented. Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Percentage values are rounded-off. | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Number | Percentage of participants | Baseline (Day 1), Months 6, 12 and 24 |
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| Secondary | Change From Baseline in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Months 12 and 24 | EQ-5D-5L is self-assessment questionnaire,consisting of 5 items covering 5 dimensions (mobility,self care,usual activities,pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health state). Baseline was considered as Day 1 of inclusion date to the study (Study Day 1). Change from Baseline was calculated as the post-dose visit value minus Baseline value. | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1), Months 12 and 24 |
|
|
|
| Secondary | Percentage of Participants Experiencing a Clinically Important Deterioration | Clinically important deterioration was defined as if at least one of the following conditions exists at any point of time during the observational period: decrease (>=100 milliliter [mL]) of FEV1 from Baseline (missing values are treated as no decrease); increase (>2 units) of CAT from Baseline (missing values are treated as no increase); any documented exacerbation; and all-cause mortality. Percentage of participants experiencing a clinically important deterioration during 24 months observation period have been presented. Percentage values are rounded-off. | Full Analysis Set | Posted | Number | Percentage of participants | Up to 24 months |
|
|
|
| Secondary | Time to First Moderate or Severe Exacerbation | The time to first moderate or severe exacerbation was defined as the duration between onset of first moderate or severe acute exacerbation of COPD from Day 1. Moderate exacerbations are defined as COPD exacerbations that require either systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as those requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. It was evaluated by Kaplan-Maier analysis. | Full Analysis Set. | Posted | Median | Inter-Quartile Range | Days | Up to 24 months |
|
|
|
| Secondary | Time to First Hospitalization | Time to first hospitalization is calculated as the time interval between date of study enrollment (Day 1) and the date of the first hospital admission for a relevant cause. Time to first hospitalization was analyzed using Kaplan-Meier methods. | Full Analysis Set. | Posted | Median | Inter-Quartile Range | Days | Up to 24 months |
|
|
|
| Secondary | Time to Death | Time to death is calculated as the duration between date of study enrollment (Day 1) and the date of death of a participant. Time to death was analyzed using Kaplan-Meier methods. | Full Analysis Set | Posted | Median | Inter-Quartile Range | Days | Up to 24 months |
|
|
|
| Secondary | Number of COPD Related Visits | Number of COPD related visits made by participants have been presented and categorized by type of physician (general practitioners and pneumologists). | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Number of visits | Up to 24 months |
|
|
|
| Secondary | Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Physician | The annual rate of exacerbations during the observation period (per participant per year) was assessed. Annualized rate of exacerbations was calculated as Annual exacerbation rate = total number of exacerbation/total person years. Data for mean annual rate of exacerbations categorized by general practitioners and pneumologists have been presented. | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Exacerbations per participant per year | Up to 24 months |
|
|
|
| Secondary | Mean Annual Rate of Hospitalization Due to Severe Exacerbation Over a 24-month Observation Period Categorized by Physician | Annualized rate of hospitalization due to severe exacerbations was calculated as Annual hospitalization rate=number of hospitalizations due to severe exacerbations/total person years. Severe exacerbations are defined as COPD exacerbations requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. Data for mean annual rate of hospitalization due to severe exacerbation categorized by general practitioners and pneumologists have been presented. | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Hospitalization per participant per year | Up to 24 months |
|
|
|
| Secondary | Percentage of Participants Categorized by the Site Localization of Physician and by Type of Physician | Percentage of participants have been categorized according to the site localization (East, North, South, and West Germany) of physician and type of physician (general practitioners and pneumologists). Percentage values are rounded-off. | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Number | Percentage of participants | Up to 24 months |
|
|
|
| Secondary | Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History | The annual rate of exacerbations during the observation period (per participant per year) was assessed. Annualized rate of exacerbations was calculated as Annual exacerbation rate = total number of exacerbation/total person years. Data for mean annual rate of exacerbations is presented by smoking status (Lifelong non-smoker, Current and previous smoker), peripheral blood eosinophil count (missing, <300 and >=300 cells/uL), and asthma history (missing, yes, no and unknown). Data was also categorized by the type of physician (general practitioners and pneumologists). | Full Analysis Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Exacerbations per participant per year | Up to 24 months |
|
|
|
| Secondary | Number of Participants Who Had Pneumonia and Cardiovascular Events | Number of participants who had pneumonia and cardiovascular events have been presented. | Safety Analysis Set included all participants who signed the ICF, met all inclusion criteria and none of the exclusion criteria, and completed visit 1. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Count of Participants | Participants | Up to 24 months |
|
|
|
| Secondary | Number Needed to Treat for Benefit (NNTB) for SITT Participants Compared to Non SITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events | NNTB is a metric used to assess the benefit of treatment. It indicates how many participants need to be treated to achieve one additional beneficial outcome with respect to exacerbations, pneumonia, and cardiovascular events. NNTB is presented as number of participants and is presented at Days 90 and 365 for participants on SIIT compared to non SITT. A participant is classified as SITT, if the treatment is SITT continuously for the first 365 days of observation. | Full Analysis Set. | Posted | Count of Participants | Participants | Days 90 and 365 |
|
|
|
| Secondary | Number Needed to Treat for Benefit (NNTB) for MITT Participants Compared to Non MITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events | NNTB is a metric used to assess the benefit of treatment. It indicates how many participants need to be treated to achieve one additional beneficial outcome with respect to exacerbations, pneumonia, and cardiovascular events. NNTB is presented as number of participants and is presented at Days 90 and 365 for participants on MITT compared to non MITT. A participant is classified as MITT, if the treatment is MITT continuously for the first 365 days of observation. | Full Analysis Set | Posted | Count of Participants | Participants | Days 90 and 365 |
|
|
|
| Secondary | Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants Whose Triple Therapies Interrupted by ICS and/or LAMA "Off/on" Periods Compared to Other Triple Therapies | NNTB is a metric used to assess the benefit of treatment. It indicates how many participants need to be treated to achieve one additional beneficial outcome with respect to exacerbations, pneumonia, and cardiovascular events. NNTB is presented as number of participants and is presented at Days 90 and 365 for participants whose triple therapies were interrupted by ICS and/or LAMA "off/on" periods compared to other triple therapies. | Full Analysis Set | Posted | Count of Participants | Participants | Days 90 and 365 |
|
|
|
| Secondary | Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants With Switch of Triple Therapies Between SITT and MITT Compared to no Switch | NNTB is a metric used to assess the benefit of treatment. It indicates how many participants need to be treated to achieve one additional beneficial outcome with respect to exacerbations, pneumonia, and cardiovascular events. NNTB is presented as number of participants and is presented at Days 90 and 365 for participants whose triple therapies were switched between SITT and MITT compared to no switch. A participants is classified as switch, if there is no de-escalation of therapy, but at least one switch between SITT and MITT within the first 365 days of observation. | Full Analysis Set | Posted | Count of Participants | Participants | Days 90 and 365 |
|
|
|
| 51 |
| 1,196 |
| 142 |
| 1,196 |
| 16 |
| 1,196 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Tracheomalacia | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 27 | Systematic Assessment |
|
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA version 27 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA version 27 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA version 27 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA version 27 | Systematic Assessment |
|
| Atypical mycobacterial infection | Infections and infestations | MedDRA version 27 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA version 27 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA version 27 | Systematic Assessment |
|
| Pneumonia aspiration | Infections and infestations | MedDRA version 27 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA version 27 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA version 27 | Systematic Assessment |
|
| Tick-borne viral encephalitis | Infections and infestations | MedDRA version 27 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA version 27 | Systematic Assessment |
|
| Death | General disorders | MedDRA version 27 | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA version 27 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA version 27 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA version 27 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA version 27 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA version 27 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA version 27 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA version 27 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA version 27 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA version 27 | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA version 27 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA version 27 | Systematic Assessment |
|
| Cor pulmonale chronic | Cardiac disorders | MedDRA version 27 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA version 27 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA version 27 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA version 27 | Systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27 | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27 | Systematic Assessment |
|
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27 | Systematic Assessment |
|
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27 | Systematic Assessment |
|
| Elastofibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27 | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27 | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27 | Systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27 | Systematic Assessment |
|
| Oropharyngeal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27 | Systematic Assessment |
|
| Pancoast's tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27 | Systematic Assessment |
|
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA version 27 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA version 27 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA version 27 | Systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA version 27 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA version 27 | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA version 27 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA version 27 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA version 27 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 27 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA version 27 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA version 27 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA version 27 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA version 27 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA version 27 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA version 27 | Systematic Assessment |
|
| Dementia Alzheimer's type | Nervous system disorders | MedDRA version 27 | Systematic Assessment |
|
| Senile dementia | Nervous system disorders | MedDRA version 27 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA version 27 | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Duodenal perforation | Gastrointestinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Gastrointestinal vascular malformation haemorrhagic | Gastrointestinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA version 27 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 27 | Systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA version 27 | Systematic Assessment |
|
| Muscle swelling | Musculoskeletal and connective tissue disorders | MedDRA version 27 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 27 | Systematic Assessment |
|
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA version 27 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA version 27 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA version 27 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA version 27 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA version 27 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA version 27 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 27 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 27 | Systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA version 27 | Systematic Assessment |
|
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA version 27 | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA version 27 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA version 27 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA version 27 | Systematic Assessment |
|
| Normocytic anaemia | Blood and lymphatic system disorders | MedDRA version 27 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA version 27 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA version 27 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 27 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 27 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 27 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 27 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 27 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA version 27 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 27 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA version 27 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA version 27 | Systematic Assessment |
|
| C-reactive protein abnormal | Investigations | MedDRA version 27 | Systematic Assessment |
|
| International normalised ratio abnormal | Investigations | MedDRA version 27 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA version 27 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| >=300 cells/uL |
|
| Title | Measurements |
|---|---|
|
| West Germany |
|
| Title | Measurements |
|---|
|
| GOLD 4 |
|
| Missing |
|
| Title | Measurements |
|---|
|
| GOLD D |
|
| Missing |
|
|
| Month 6: Oral betamimetics |
|
|
| Month 6: Immunotherapy |
|
|
| Month 6: Antibiotics for respiratory indications |
|
|
| Month 6: Other substances with cardiac or respiratory effects |
|
|
| Month 12: Oral glucocorticosteroids |
|
|
| Month 12: Leukotriene receptor antagonist |
|
|
| Month 12: Oral betamimetics |
|
|
| Month 12: Immunotherapy |
|
|
| Month 12: Antibiotics for respiratory indications |
|
|
| Month 12: Other substances with cardiac or respiratory effects |
|
|
| Month 24: Oral glucocorticosteroids |
|
|
| Month 24: Leukotriene receptor antagonist |
|
|
| Month 24: Oral betamimetics |
|
|
| Month 24: Immunotherapy |
|
|
| Month 24: Antibiotics for respiratory indications |
|
|
| Month 24: Other substances with cardiac or respiratory effects |
|
|
| Title | Measurements |
|---|---|
|
|
| Month 6: Previous smoker |
|
|
| Month 12: Lifelong non-smoker |
|
|
| Month 12: Current smoker |
|
|
| Month 12: Previous smoker |
|
|
| Month 24: Lifelong non-smoker |
|
|
| Month 24: Current smoker |
|
|
| Month 24: Previous smoker |
|
|
|
| Month 12 |
|
|
| Month 24 |
|
|
|
| Up to 3 months prior to Month 12 |
|
|
| Up to 3 months prior to Month 24 |
|
|
|
| Baseline (Day 1): >=20 |
|
|
| Month 6: <=10 |
|
|
| Month 6: 11-19 |
|
|
| Month 6: >=20 |
|
|
| Month 12: <=10 |
|
|
| Month 12: 11-19 |
|
|
| Month 12: >=20 |
|
|
| Month 24: <=10 |
|
|
| Month 24: 11-19 |
|
|
| Month 24: >=20 |
|
|
|
| Month 6: Missing |
|
|
| Month 12: <300 cells/uL |
|
|
| Month 12: >=300 cells/uL |
|
|
| Month 12: Missing |
|
|
| Month 24: <300 cells/uL |
|
|
| Month 24: >=300 cells/uL |
|
|
| Month 24: Missing |
|
|
|
| Overall: Deteriorating quality of life and/or lung function despite long-term therapy |
|
|
| Overall: one or more exacerbations |
|
|
| Overall: Acute exacerbation |
|
|
| Overall: Hospitalization because of major exacerbation/other reason |
|
|
| Overall: Exacerbation prophylaxis |
|
|
| Overall: Participants wish to change medication or device |
|
|
| Overall: Other |
|
|
| Overall: Missing |
|
|
| General practitioners: Symptomatic despite previous dual therapy with ICS/LABA |
|
|
| General practitioners: Symptomatic despite previous dual therapy with LAMA/LABA |
|
|
| General practitioners: Deteriorating quality of life and/or lung function despite long-term therapy |
|
|
| General practitioners: one or more exacerbations |
|
|
| General practitioners: Acute exacerbation |
|
|
| General practitioners: Hospitalization because of major exacerbation/other reason |
|
|
| General practitioners: Exacerbation prophylaxis |
|
|
| General practitioners: Participants wish to change medication or device |
|
|
| General practitioners: Other |
|
|
| General practitioners: Missing |
|
|
| Pneumologists: Symptomatic despite previous dual therapy with ICS/LABA |
|
|
| Pneumologists: Symptomatic despite previous dual therapy with LAMA/LABA |
|
|
| Pneumologists: Deteriorating quality of life and/or lung function despite long-term therapy |
|
|
| Pneumologists: one or more exacerbations |
|
|
| Pneumologists: Acute exacerbation |
|
|
| Pneumologists: Hospitalization because of major exacerbation/other reason |
|
|
| Pneumologists: Exacerbation prophylaxis |
|
|
| Pneumologists: Participants wish to change medication or device |
|
|
| Pneumologists: Other |
|
|
| Pneumologists: Missing |
|
|
| Title | Measurements |
|---|---|
|
| No re-escalation |
|
|
| GP: Deteriorating quality of life (QoL) and/or lung function despite long-term therapy |
|
|
| GP: One or more exacerbations |
|
|
| GP: Acute exacerbation |
|
|
| GP: Hospitalization because of major exacerbation/other reason |
|
|
| GP: Exacerbation prophylaxis |
|
|
| GP: Participants wish to change medication or device |
|
|
| GP: Switching from open TT (MITT, various inhalers) to closed TT (SITT, one inhaler) |
|
|
| GP: Change from twice daily to once daily |
|
|
| GP: Switching to a different type of inhaler |
|
|
| GP: Insufficient effectiveness of the previous medication |
|
|
| GP: Recommendation of guideline (e.g. discontinuation of ICS) |
|
|
| GP: Recommendation from a referring pulmonologist or acute care clinic |
|
|
| GP: Adverse Event |
|
|
| GP: Symptomatic under existing triple therapy |
|
|
| GP: Other |
|
|
| GP: Missing |
|
|
| Pneumologists: Symptomatic despite previous dual therapy with ICS/LABA |
|
|
| Pneumologists: Symptomatic despite previous dual therapy with LAMA/LABA |
|
|
| Pneumologists: Deteriorating QoL and/or lung function despite long-term therapy |
|
|
| Pneumologists: One or more exacerbations |
|
|
| Pneumologists: Acute exacerbation |
|
|
| Pneumologists: Hospitalization because of major exacerbation/other reason |
|
|
| Pneumologists: Exacerbation prophylaxis |
|
|
| Pneumologists: Participants wish to change medication or device |
|
|
| Pneumologists:Switching from open TT(MITT, various inhalers) to closed TT(SITT, 1 inhaler) |
|
|
| Pneumologists: Change from twice daily to once daily |
|
|
| Pneumologists: Switching to a different type of inhaler |
|
|
| Pneumologists: Insufficient effectiveness of the previous medication |
|
|
| Pneumologists: Recommendation of guideline (e.g. discontinuation of ICS) |
|
|
| Pneumologists: Recommendation from a referring pulmonologist or acute care clinic |
|
|
| Pneumologists: Adverse Event |
|
|
| Pneumologists: Symptomatic under existing triple therapy |
|
|
| Pneumologists: Other |
|
|
| Pneumologists: Missing |
|
|
|
| One or more exacerbations |
|
| Acute exacerbation |
|
| Hospitalization because of major exacerbation/other reason |
|
| Exacerbation prophylaxis |
|
| Participants wish to change medication or device |
|
| Switching from open TT (MITT, various inhalers) to closed TT (SITT, one inhaler) |
|
| Change from twice daily to once daily |
|
| Switching to a different type of inhaler |
|
| Insufficient effectiveness of the previous medication |
|
| Recommendation of guideline (e.g. discontinuation of ICS) |
|
| Recommendation from a referring pulmonologist or acute care clinic |
|
| Adverse Event |
|
| Symptomatic under existing triple therapy |
|
| Other |
|
| Missing |
|
|
| One or more exacerbations |
|
| Acute exacerbation |
|
| Hospitalization because of major exacerbation/other reason |
|
| Exacerbation prophylaxis |
|
| Participants wish to change medication or device |
|
| Switching from open TT (MITT, various inhalers) to closed TT (SITT, one inhaler) |
|
| Change from twice daily to once daily |
|
| Switching to a different type of inhaler |
|
| Insufficient effectiveness of the previous medication |
|
| Recommendation of guideline (e.g. discontinuation of ICS) |
|
| Recommendation from a referring pulmonologist or acute care clinic |
|
| Adverse Event |
|
| Symptomatic under existing triple therapy |
|
| Other |
|
| Missing |
|
|
| One or more exacerbations |
|
| Acute exacerbation |
|
| Hospitalization because of major exacerbation/other reason |
|
| Exacerbation prophylaxis |
|
| Participants wish to change medication or device |
|
| Switching from open TT (MITT, various inhalers) to closed TT (SITT, one inhaler) |
|
| Change from twice daily to once daily |
|
| Switching to a different type of inhaler |
|
| Insufficient effectiveness of the previous medication |
|
| Recommendation of guideline (e.g. discontinuation of ICS) |
|
| Recommendation from a referring pulmonologist or acute care clinic |
|
| Adverse Event |
|
| Symptomatic under existing triple therapy |
|
| Other |
|
| Missing |
|
|
| Smoking status: Current smoker |
|
|
| Smoking status: Previous smoker |
|
|
| Eosinophil count: <300 cells/uL |
|
|
| Eosinophil count: >=300 cells/uL |
|
|
| Eosinophil count: Missing |
|
|
| Asthma history: No |
|
|
| Asthma history: Yes |
|
|
| Asthma history: Missing |
|
|
| Asthma history: Unknown |
|
|
|
| Peripheral blood EOS: >=300 cells/uL |
|
|
| Peripheral blood EOS: Missing |
|
|
| Smoking history: Lifelong non-smoker |
|
|
| Smoking history: Current smoker |
|
|
| Smoking history: Previous smoker |
|
|
| Asthma history: No |
|
|
| Asthma history: Yes |
|
|
| Asthma history: Unknown |
|
|
| Asthma history: Missing |
|
|
|
| Peripheral blood EOS: >=300 cells/uL |
|
|
| Peripheral blood EOS: Missing |
|
|
| Smoking history: Lifelong non-smoker |
|
|
| Smoking history: Current smoker |
|
|
| Smoking history: Previous smoker |
|
|
| Asthma history: No |
|
|
| Asthma history: Yes |
|
|
| Asthma history: Unknown |
|
|
| Asthma history: Missing |
|
|
|
| Peripheral blood EOS: >=300 cells/uL |
|
|
| Peripheral blood EOS: Missing |
|
|
| Smoking history: Lifelong non-smoker |
|
|
| Smoking history: Current smoker |
|
|
| Smoking history: Previous smoker |
|
|
| Asthma history: No |
|
|
| Asthma history: Yes |
|
|
| Asthma history: Unknown |
|
|
| Asthma history: Missing |
|
|
|
| Peripheral blood EOS: >=300 cells/uL |
|
|
| Peripheral blood EOS: Missing |
|
|
| Smoking history: Lifelong non-smoker |
|
|
| Smoking history: Current smoker |
|
|
| Smoking history: Previous smoker |
|
|
| Asthma history: No |
|
|
| Asthma history: Yes |
|
|
| Asthma history: Unknown |
|
|
| Asthma history: Missing |
|
|
|
| Peripheral blood EOS: >=300 cells/uL |
|
|
| Peripheral blood EOS: Missing |
|
|
| Smoking history: Lifelong non-smoker |
|
|
| Smoking history: Current smoker |
|
|
| Smoking history: Previous smoker |
|
|
| Asthma history: No |
|
|
| Asthma history: Yes |
|
|
| Asthma history: Unknown |
|
|
| Asthma history: Missing |
|
|
|
| Peripheral blood EOS: >=300 cells/uL |
|
|
| Peripheral blood EOS: Missing |
|
|
| Smoking history: Lifelong non-smoker |
|
|
| Smoking history: Current smoker |
|
|
| Smoking history: Previous smoker |
|
|
| Asthma history: No |
|
|
| Asthma history: Yes |
|
|
| Asthma history: Unknown |
|
|
| Asthma history: Missing |
|
|
|
| Month 6: More symptoms |
|
|
| Month 12: Stable symptoms |
|
|
| Month 12: Less symptoms |
|
|
| Month 12: More symptoms |
|
|
| Month 24: Stable symptoms |
|
|
| Month 24: Less symptoms |
|
|
| Month 24: More symptoms |
|
|
|
|
|
|
|
| General practitioners: South Germany |
|
|
| General practitioners: West Germany |
|
|
| Pneumologists: East Germany |
|
|
| Pneumologists: North Germany |
|
|
| Pneumologists: South Germany |
|
|
| Pneumologists: West Germany |
|
|
|
| General practitioners: Smoking status- Previous smoker |
|
|
| General practitioners: Eosinophil count- Missing |
|
|
| General practitioners: Eosinophil count- <300 cells/uL |
|
|
| General practitioners: Eosinophil count- >=300 cells/uL |
|
|
| General practitioners: Asthma history- Missing |
|
|
| General practitioners: Asthma history- No |
|
|
| General practitioners: Asthma history- Yes |
|
|
| General practitioners: Asthma history- Unknown |
|
|
| Pneumologists: Smoking status- Lifelong non-smoker |
|
|
| Pneumologists: Smoking status- Current smoker |
|
|
| Pneumologists: Smoking status- Previous smoker |
|
|
| Pneumologists: Eosinophil count- Missing |
|
|
| Pneumologists: Eosinophil count- <300 cells/uL |
|
|
| Pneumologists: Eosinophil count- >=300 cells/uL |
|
|
| Pneumologists: Asthma history- Missing |
|
|
| Pneumologists: Asthma history- No |
|
|
| Pneumologists: Asthma history- Yes |
|
|
| Pneumologists: Asthma history- Unknown |
|
|
| Title | Measurements |
|---|---|
|
| Day 365: NNTB with respect to Pneumonia |
|
| Day 90: NNTB with respect to Cardiovascular events |
|
| Day 365: NNTB with respect to Cardiovascular events |
|
| Title | Measurements |
|---|---|
|
| Day 365: NNTB with respect to Pneumonia |
|
| Day 90: NNTB with respect to Cardiovascular events |
|
| Day 365: NNTB with respect to Cardiovascular events |
|
| Day 90: NNTB with respect to Pneumonia |
|
| Day 365: NNTB with respect to Pneumonia |
|
| Day 90: NNTB with respect to Cardiovascular events |
|
| Day 365: NNTB with respect to Cardiovascular events |
|
| Day 90: NNTB with respect to Pneumonia |
|
| Day 365: NNTB with respect to Pneumonia |
|
| Day 90: NNTB with respect to Cardiovascular events |
|
| Day 365: NNTB with respect to Cardiovascular events |
|