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A retrospective analysis study in COPD patients for an exact follow-up period of 12 months (in subgroup analyses: 24 and 36 months); censoring of patients will only be done in case a patient died during the respective follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Pulmonary Disease, Chronic Obstructive |
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| Measure | Description | Time Frame |
|---|---|---|
| Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample | Description of real-life drug treatment in patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 12 months after the index date (date of incident (first) diagnosis of COPD). Reported is the percentage of patients per treatment and therapy line. The arms are not mutually exclusive, as patients switched to another treatment during follow-up period. COPD-12 sample: Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 12 months since index date (COPD-12). LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids. | Up to 12 months after the index date. |
| Description of Real-life Drug Treatment After Incident Diagnosis - COPD-24 Sample | Description of real-life drug treatment in patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 24 months after the index date (date of incident (first) diagnosis of COPD). Reported is the percentage of patients per treatment and therapy line. The arms are not mutually exclusive, as patients switched to another treatment during follow-up period. COPD-24 sample: Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 24 months since index date (COPD-24). LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids. | Up to 24 months after the index date. |
| Description of Real-life Drug Treatment After Incident Diagnosis - COPD-36 Sample | Description of real-life drug treatment in patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 36 months after the index date (date of incident (first) diagnosis of COPD). Reported is the percentage of patients per treatment and therapy line. The arms are not mutually exclusive, as patients switched to another treatment during follow-up period. COPD-36 sample: Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 36 months since index date (COPD-36). LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Incident COPD-patients With Initial Treatment Not in Line Treatment Guideline - COPD-12 Sample | Percentage of incident chronic obstructive pulmonary disease (COPD) patients with initial drug treatment not in line with 2012/2018 german guidelines. Results are reported for COPD-12 sample. According to guidelines the initial treatment with long-acting bronchodilators should generally not include use of Inhaled corticosteroids (ICS) (both guidelines). Based on the 2012 guideline, a therapy with long-acting bronchodilators should not start with a combination of Long-acting beta agonist (LABA) + Long-acting muscarinic antagonist (LAMA) or triple therapy of LAMA+LABA+ ICS. |
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Inclusion Criteria:
Exclusion Criteria:
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A retrospective analysis of patients with Chronic Obstructive Pulmonary Disease (COPD) based on current German COPD guidleines.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for pharmacoeconomics and pharmaceutical logistics e.V (IPAM) | Wismar | 23966 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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Only subjects that met all inclusion and none of the exclusion criteria were included in the study.
A retrospective, non-interventional, longitudinal study including real-world data from german claims data (2015-2018) to describe the real-world drug treatment in patients of newly diagnosed chronic obstructive pulmonary disease (COPD).
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| ID | Title | Description |
|---|---|---|
| FG000 | COPD-FULL Sample | Patients with incident chronic obstructive pulmonary disease (COPD) between April 2015 and March 2018 from German claims database were followed for up to 48 months. Patients were censored in case of death or loss to follow-up. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2019 |
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| Up to 36 months after the index date. |
| Number of Observed Treatment Lines - COPD-12, COPD-24, COPD-36 and COPD-FULL Sample | Number of treatment lines an observed patient received in the first 12/24/36 and 48 months after incident diagnosis. | Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively. |
| Percentage of Patients Per Most Frequently Prescribed Non-COPD Agents in COPD-FULL, COPD-12, COPD-24 and COPD-36 Samples | Percentage of participants per most frequently prescribed non-COPD agents in the first 12/24/36 and 48 months after incident diagnosis. GERD: Gastroesophageal reflux disease. | Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively. |
| At index date. |
| Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Triple Therapy) | Percentage of incident chronic obstructive pulmonary disease (COPD) patients with drug treatment not in line with 2012/2018 german guidelines. Results are reported for COPD-12 sample, who received triple therapy (Long-acting beta agonist (LABA) + Long-acting muscarinic antagonist (LAMA) + Inhaled corticosteroids (ICS)) within the first 12 months after incident diagnosis. According to both guidelines (2012/2018) a triple combination treatment should not be prescribed if only 1 or less confirmed outpatient diagnoses and no inpatient diagnosis of a COPD exacerbation (ICD-10 J44.1) before date of prescription of a triple therapy. FEV1: Forced expiratory volume (in 1 second). | At first day of triple therapy prescription, (which is not the index date), up to 12 months. |
| Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Escalation Therapy) | Percentage of incident chronic obstructive pulmonary disease (COPD) patients with drug treatment not in line with 2012/2018 german guidelines. Results are reported for patients in COPD-12 sample, with treatment escalation (mono therapy to Long-acting beta agonist (LABA)/ Long-acting muscarinic antagonist (LAMA)/ Inhaled corticosteroids (ICS), LABA/ICS or LAMA/LABA to LABA/LAMA/ICS) within the first 12 months after index date. According to guidelines patients should not receive a treatment intensification without any previous visit of a pneumologist or hospital (same quarter or previous quarter). | Up to 12 months after index date. |
| Percentage of Patients With Exacerbations After Incident Diagnosis in COPD-12, COPD-24, COPD-36 and COPD-FULL Samples | Description of exacerbation (severe exacerbations associated with hospitalizations) frequency of patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 12, 24, 36 and 48 months after incident diagnosis. Reported is the percentage of patients with exacerbations by the following categories: More or equal than one exacerbation (≥ 1) ;
| Up to 12,24, 36 and 48 months after index date, for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively. |
| Number of Yearly Visits Per Outpatient Treatment in COPD-12, COPD-24 and COPD-36 Samples | Description of health-care resource use (HCRU) in the first 12/24/36 months after incident diagnosis - Number of yearly visits (outpatient treatment). Following categories are reported: Number of yearly general practitioner (GP) visits; Number of yearly pulmonologist visits; Number of yearly other specialist (primarily Ophthalmologist, Ear, Nose and Throat (ENT) specialist and Orthopedist) visits. Reported is the average number of yearly visits, per observed patient year. | Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively. |
| Number of Yearly Hospitalizations in COPD-12, COPD-24 and COPD-36 Samples | Description of health-care resource use in the first 12/24/36 months after incident diagnosis: Number of yearly hospitalizations (inpatient treatment). Following categories of inpatient treatment are reported: Number of yearly hospitalizations with exacerbations (J44.1); Number of yearly hospitalizations with exacerbations, any COPD diagnosis (J44); Number of yearly hospitalizations with non-COPD diagnosis. Results are reported by follow-up time and available Disease Management Program (DMP) data. | Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively. |
| Time to First All-cause Hospitalization in COPD-12, COPD-24, COPD-36 Samples | Description of health-care resource use in the first 12/24/36 months after incident diagnosis in patients with chronic obstructive pulmonary disease (COPD). Reported is time to first all-cause hospitalization in days (inpatient treatment). | Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively. |
| Description of Direct Treatment Cost After Incident Diagnosis in COPD-12, COPD-24 and COPD-36 Samples | Description of direct treatment cost in the first 12/24/36 months after incident diagnosis - yearly costs in incident chronic obstructive pulmonary disease (COPD) patients. LTOT: Long-Term Oxygen Therapy. | Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively. |
| Prescription of Medication in COPD-12, COPD-24 and COPD-36 Samples | Description of health-care resource use in the first 12/24/36 months after incident diagnosis - Prescription of medication. Top-5 prescription of non-COPD medication: Beta-blocking agents; Anti-thrombotic agents; Other analgesics & antipyretics; High-ceiling diuretics; Drugs for peptic ulcer or Gastroesophageal reflux disease (GERD). Other prescriptions: Antibiotics for systemic use (ATC J02AA); Antibiotics + corticosteroids (ATC D07C). Reported is number of yearly prescription. | Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively. |
| Number of Patients With Long Term Oxygen Therapy (LTOT) in COPD-12, COPD-24 and COPD-36 Samples | Description of health-care resource use in the first 12/24/36 months after incident diagnosis - Number of Patients with Long Term Oxygen Therapy (LTOT). | Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively. |
| Time From Index Date Until Start of Long-term Oxygen Therapy (LTOT) - COPD-12, COPD-24 and COPD-36 Samples | Time from index date until start of long-term oxygen therapy (LTOT) in days in the first 12/24/36 months after incident diagnosis. | Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively. |
| Time From Index Date Until First Exacerbation - COPD-FULL, COPD-12, COPD-24 and COPD-36 | Time from index date until first exacerbation, in the first 12/24/36/48 months after incident diagnosis. Only severe exacerbations leading to an inpatient hospitalization after index date (documented as main diagnosis: ICD-10 J44.1) are considered. | Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively. |
| Average Number of Yearly Exacerbations During Follow-up - COPD-FULL, COPD-12, COPD-24 and COPD-36 | Average number of yearly exacerbations in the first 12/24/36 and 48 months after incident diagnosis. | Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively. |
| Average Medication Costs Per Year - COPD-12, COPD-24 and COPD-36 | Description of yearly costs in incident chronic obstructive pulmonary disease (COPD) patients. Cost of non-COPD-medication are based on the top-10 prescribed on non-COPD drug therapies. | Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 respectively. |
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Patients with newly diagnosed chronic obstructive pulmonary disease (Incident COPD patients).
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| ID | Title | Description |
|---|---|---|
| BG000 | COPD-FULL Sample | Patients with incident chronic obstructive pulmonary disease (COPD) between April 2015 and March 2018 from German claims database were followed for up to 48 months. Patients were censored in case of death or loss to follow-up. |
| Units | Counts |
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| 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 | Standard Deviation | Years |
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| Sex/Gender, Customized | Number | Percentage of participants |
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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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| 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 | ||||||||||||||||||||||||||||||||
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| Primary | Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample | Description of real-life drug treatment in patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 12 months after the index date (date of incident (first) diagnosis of COPD). Reported is the percentage of patients per treatment and therapy line. The arms are not mutually exclusive, as patients switched to another treatment during follow-up period. COPD-12 sample: Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 12 months since index date (COPD-12). LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids. | All patients included in the COPD-12 sample, who received any long term-COPD treatment. Patients are reported by therapy line (arms are not mutually exclusive). The number of patients who received COPD-12 Fourth Line Therapy is less than 5% of the patient population (N=8238). As defined in the protocol, data collected only for treatment pattern combinations that were observed in >5% in patient population. | Posted | Number | Percentage of Patients | Up to 12 months after the index date. |
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| Primary | Description of Real-life Drug Treatment After Incident Diagnosis - COPD-24 Sample | Description of real-life drug treatment in patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 24 months after the index date (date of incident (first) diagnosis of COPD). Reported is the percentage of patients per treatment and therapy line. The arms are not mutually exclusive, as patients switched to another treatment during follow-up period. COPD-24 sample: Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 24 months since index date (COPD-24). LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids. | All patients included in the COPD-24 sample, who received any long term-COPD treatment. Patients are reported by therapy line (arms are not mutually exclusive). | Posted | Number | Percentage of Patients | Up to 24 months after the index date. |
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| Primary | Description of Real-life Drug Treatment After Incident Diagnosis - COPD-36 Sample | Description of real-life drug treatment in patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 36 months after the index date (date of incident (first) diagnosis of COPD). Reported is the percentage of patients per treatment and therapy line. The arms are not mutually exclusive, as patients switched to another treatment during follow-up period. COPD-36 sample: Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 36 months since index date (COPD-36). LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids. | All patients included in the COPD-36 sample, who received any long term-COPD treatment. Patients are reported by therapy line (arms are not mutually exclusive). | Posted | Number | Percentage of Patients | Up to 36 months after the index date. |
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| Primary | Number of Observed Treatment Lines - COPD-12, COPD-24, COPD-36 and COPD-FULL Sample | Number of treatment lines an observed patient received in the first 12/24/36 and 48 months after incident diagnosis. | All patients with newly diagnosed (incident) COPD and who received any long-term COPD treatment. Incident COPD-patients are reported by follow-up period (12, 24, 36 and 48 months). Arms are not mutually exclusive. | Posted | Mean | Standard Deviation | Treatment lines | Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively. |
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| Primary | Percentage of Patients Per Most Frequently Prescribed Non-COPD Agents in COPD-FULL, COPD-12, COPD-24 and COPD-36 Samples | Percentage of participants per most frequently prescribed non-COPD agents in the first 12/24/36 and 48 months after incident diagnosis. GERD: Gastroesophageal reflux disease. | All patients with newly diagnosed (incident) chronic obstructive pulmonary disease. Incident COPD-patients were reported by follow-up time (12, 24, 36 and 48 months). Arms are not mutually exclusive. | Posted | Number | Percentage of participants | Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively. |
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| Secondary | Percentage of Incident COPD-patients With Initial Treatment Not in Line Treatment Guideline - COPD-12 Sample | Percentage of incident chronic obstructive pulmonary disease (COPD) patients with initial drug treatment not in line with 2012/2018 german guidelines. Results are reported for COPD-12 sample. According to guidelines the initial treatment with long-acting bronchodilators should generally not include use of Inhaled corticosteroids (ICS) (both guidelines). Based on the 2012 guideline, a therapy with long-acting bronchodilators should not start with a combination of Long-acting beta agonist (LABA) + Long-acting muscarinic antagonist (LAMA) or triple therapy of LAMA+LABA+ ICS. | All patients with newly diagnosed chronic obstructive pulmonary disease (COPD), with a follow-up of 12 months since index date (COPD-12). | Posted | Number | Percentage of Patients | At index date. |
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| Secondary | Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Triple Therapy) | Percentage of incident chronic obstructive pulmonary disease (COPD) patients with drug treatment not in line with 2012/2018 german guidelines. Results are reported for COPD-12 sample, who received triple therapy (Long-acting beta agonist (LABA) + Long-acting muscarinic antagonist (LAMA) + Inhaled corticosteroids (ICS)) within the first 12 months after incident diagnosis. According to both guidelines (2012/2018) a triple combination treatment should not be prescribed if only 1 or less confirmed outpatient diagnoses and no inpatient diagnosis of a COPD exacerbation (ICD-10 J44.1) before date of prescription of a triple therapy. FEV1: Forced expiratory volume (in 1 second). | All patients included in the COPD-12 sample, who received triple therapy within the first 12 months after incident COPD. | Posted | Number | Percentage of Patients | At first day of triple therapy prescription, (which is not the index date), up to 12 months. |
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| Secondary | Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Escalation Therapy) | Percentage of incident chronic obstructive pulmonary disease (COPD) patients with drug treatment not in line with 2012/2018 german guidelines. Results are reported for patients in COPD-12 sample, with treatment escalation (mono therapy to Long-acting beta agonist (LABA)/ Long-acting muscarinic antagonist (LAMA)/ Inhaled corticosteroids (ICS), LABA/ICS or LAMA/LABA to LABA/LAMA/ICS) within the first 12 months after index date. According to guidelines patients should not receive a treatment intensification without any previous visit of a pneumologist or hospital (same quarter or previous quarter). | All patients in the COPD-12 sample with treatment escalation in the first 12 months after index date. | Posted | Number | Percentage of Patients | Up to 12 months after index date. |
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| Secondary | Percentage of Patients With Exacerbations After Incident Diagnosis in COPD-12, COPD-24, COPD-36 and COPD-FULL Samples | Description of exacerbation (severe exacerbations associated with hospitalizations) frequency of patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 12, 24, 36 and 48 months after incident diagnosis. Reported is the percentage of patients with exacerbations by the following categories: More or equal than one exacerbation (≥ 1) ;
| All patients with newly diagnosed (incident) chronic obstructive pulmonary disease. Incident COPD-patients were reported by follow-up time (12, 24, 36 and 48 months), arms are not mutually exclusive. | Posted | Number | Percentage of participants | Up to 12,24, 36 and 48 months after index date, for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively. |
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| Secondary | Number of Yearly Visits Per Outpatient Treatment in COPD-12, COPD-24 and COPD-36 Samples | Description of health-care resource use (HCRU) in the first 12/24/36 months after incident diagnosis - Number of yearly visits (outpatient treatment). Following categories are reported: Number of yearly general practitioner (GP) visits; Number of yearly pulmonologist visits; Number of yearly other specialist (primarily Ophthalmologist, Ear, Nose and Throat (ENT) specialist and Orthopedist) visits. Reported is the average number of yearly visits, per observed patient year. | Patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD). Incident COPD-patients were reported by follow-up time (COPD-12, COPD-24, COPD-36) and available Disease Management Program (DMP) data. Arms are not mutually exclusive. | Posted | Mean | Standard Deviation | Yearly visits | Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively. |
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| Secondary | Number of Yearly Hospitalizations in COPD-12, COPD-24 and COPD-36 Samples | Description of health-care resource use in the first 12/24/36 months after incident diagnosis: Number of yearly hospitalizations (inpatient treatment). Following categories of inpatient treatment are reported: Number of yearly hospitalizations with exacerbations (J44.1); Number of yearly hospitalizations with exacerbations, any COPD diagnosis (J44); Number of yearly hospitalizations with non-COPD diagnosis. Results are reported by follow-up time and available Disease Management Program (DMP) data. | Patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD). Incident COPD-patients were reported by follow-up time (12, 24 and 36 months) and available Disease Management Program (DMP) data. Arms are not mutually exclusive. | Posted | Mean | Standard Deviation | Yearly hospitalizations | Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively. |
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| Secondary | Time to First All-cause Hospitalization in COPD-12, COPD-24, COPD-36 Samples | Description of health-care resource use in the first 12/24/36 months after incident diagnosis in patients with chronic obstructive pulmonary disease (COPD). Reported is time to first all-cause hospitalization in days (inpatient treatment). | Patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD). Incident COPD-patients were reported by follow-up time (12, 24 and 36 months) and available Disease Management Program (DMP) data. Arms are not mutually exclusive. | Posted | Median | Inter-Quartile Range | Days | Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively. |
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| Secondary | Description of Direct Treatment Cost After Incident Diagnosis in COPD-12, COPD-24 and COPD-36 Samples | Description of direct treatment cost in the first 12/24/36 months after incident diagnosis - yearly costs in incident chronic obstructive pulmonary disease (COPD) patients. LTOT: Long-Term Oxygen Therapy. | Patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD). Incident COPD-patients were reported by follow-up time (12, 24 and 36 months) and available Disease Management Program (DMP)-data. Arms are not mutually exclusive. | Posted | Number | Euro per Person-year | Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively. |
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| Secondary | Prescription of Medication in COPD-12, COPD-24 and COPD-36 Samples | Description of health-care resource use in the first 12/24/36 months after incident diagnosis - Prescription of medication. Top-5 prescription of non-COPD medication: Beta-blocking agents; Anti-thrombotic agents; Other analgesics & antipyretics; High-ceiling diuretics; Drugs for peptic ulcer or Gastroesophageal reflux disease (GERD). Other prescriptions: Antibiotics for systemic use (ATC J02AA); Antibiotics + corticosteroids (ATC D07C). Reported is number of yearly prescription. | Patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD). Incident COPD-patients were reported by follow-up time (12, 24 and 36 months). Arms are not mutually exclusive. | Posted | Mean | Standard Deviation | Yearly prescription (of medication) | Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively. |
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| Secondary | Number of Patients With Long Term Oxygen Therapy (LTOT) in COPD-12, COPD-24 and COPD-36 Samples | Description of health-care resource use in the first 12/24/36 months after incident diagnosis - Number of Patients with Long Term Oxygen Therapy (LTOT). | Patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD). Incident COPD-patients were reported by follow-up time (12, 24 and 36 months). | Posted | Count of Participants | Participants | Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively. |
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| Secondary | Time From Index Date Until Start of Long-term Oxygen Therapy (LTOT) - COPD-12, COPD-24 and COPD-36 Samples | Time from index date until start of long-term oxygen therapy (LTOT) in days in the first 12/24/36 months after incident diagnosis. | Patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD). Incident COPD-patients were reported by follow-up time (12, 24 and 36 months) and available Disease Management Program (DMP) data. Only patients with any observed LTOT are included. | Posted | Mean | Standard Deviation | Days | Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively. |
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| Secondary | Time From Index Date Until First Exacerbation - COPD-FULL, COPD-12, COPD-24 and COPD-36 | Time from index date until first exacerbation, in the first 12/24/36/48 months after incident diagnosis. Only severe exacerbations leading to an inpatient hospitalization after index date (documented as main diagnosis: ICD-10 J44.1) are considered. | All patients with newly diagnosed (incident) chronic obstructive pulmonary disease. Incident COPD-patients were reported by follow-up time (12, 24, 36 and 48 months). Only patients with severe exacerbation leading to an inpatient hospitalization are included. Arms are not mutually exclusive. | Posted | Mean | Standard Error | Months | Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively. |
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| Secondary | Average Number of Yearly Exacerbations During Follow-up - COPD-FULL, COPD-12, COPD-24 and COPD-36 | Average number of yearly exacerbations in the first 12/24/36 and 48 months after incident diagnosis. | All patients with newly diagnosed (incident) chronic obstructive pulmonary disease. Incident COPD-patients were reported by follow-up time (12, 24, 36 and 48 months). Arms are not mutually exclusive. | Posted | Mean | Standard Deviation | Exacerbations | Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively. |
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| Secondary | Average Medication Costs Per Year - COPD-12, COPD-24 and COPD-36 | Description of yearly costs in incident chronic obstructive pulmonary disease (COPD) patients. Cost of non-COPD-medication are based on the top-10 prescribed on non-COPD drug therapies. | All patients with newly diagnosed (incident) chronic obstructive pulmonary disease. Incident COPD-patients are reported by follow-up time (12, 24 and 36 months). Arms are not mutually exclusive. | Posted | Mean | Standard Deviation | Euro per Year (€/Y) | Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 respectively. |
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[All-cause Mortality]: Up to 48 months.
[All-Cause Mortality]:Patients with newly diagnosed chronic obstructive pulmonary disease.
As this is a non-interventional study with secondary use of data retrieved from a German claims database, safety monitoring and reporting on an individual case level is not applicable. Serious Adverse Events and Other Adverse Events are not collected in the database. "0" total Number of Participants at Risk means "Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed".
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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 | COPD-FULL Sample | Patients with incident chronic obstructive pulmonary disease (COPD) between April 2015 and March 2018 from German claims database were followed for up to 48 months. Patients were censored in case of death or loss to follow-up. | 5,238 | 17,464 | 0 | 0 | 0 | 0 |
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Not provided
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Jun 22, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
|
| Title | Measurements |
|---|---|
|
| LAMA + ICS |
|
| LABA |
|
| LABA + LAMA + ICS |
|
| ICS |
|
| Other (Methylxanthine, LAMA+ICS, LABA+LAMA+Methyl-xanthine) |
|
| OG002 | COPD-24 - Third Line Therapy | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 24 months since index date, who received third line therapy. |
| OG003 | COPD-24 - Fourth Line Therapy | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 24 months since index date (COPD-24), who received fourth line therapy. |
|
|
| OG002 | COPD-36 - Third Line Therapy | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 36 months since index date, who received third line therapy. |
| OG003 | COPD-36 - Fourth Line Therapy | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 36 months since index date, who received fourth line therapy. |
|
|
| OG003 | COPD-36 Sample | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date (COPD-36). |
|
|
| OG003 | COPD-36 Sample | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date (COPD-36). |
|
|
|
|
|
| OG002 | COPD-24 Sample | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date (COPD-24). |
| OG003 | COPD-36 Sample | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date (COPD-36). |
|
|
| OG002 | COPD-36 Sample | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date (COPD-36). |
| OG003 | COPD-12 Sample With DMP Data | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 12 months since index date and with available Data Management Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-12). |
|
|
| OG002 | COPD-36 Sample | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date (COPD-36). |
| OG003 | COPD-12 Sample With DMP Data | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 12 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-12). |
| OG004 | COPD-24 Sample With DMP Data | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24). |
| OG005 | COPD-36 Sample With DMP Data | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36). |
|
|
| OG003 | COPD-12 Sample With DMP Data | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 12 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). |
|
|
| OG003 | COPD-12 Patients With Available DMP-data | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 12 months since index date and with available Data Monitoring Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-12). |
|
|
| OG002 |
| COPD-36 Sample |
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2014 and march 2019, with a follow-up of 36 months since index date (COPD-36). |
|
|
|
|
| OG003 | COPD-12 Sample With DMP Data | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 12 months since index date and with available Disease Management Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-12). |
| OG004 | COPD-24 Sample With DMP Data | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date and with available Disease Management Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-24). |
| OG005 | COPD-36 Sample With DMP Data | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date and with available Disease Management Program (DMP) data (at least one entry during 3 months after index date). (COPD DMP-36). |
|
|
Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 24 months since index date (COPD-24). |
| OG003 | COPD-36 Sample | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date (COPD-36). |
|
|
| OG003 | COPD-36 | Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with a follow-up of 36 months since index date (COPD-36). |
|
|
|
|