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To assess the comparative effectiveness of combination Tiotropium and Olodaterol (Tio+Olo) (FDC) compared to combination LAMA/LABA and ICS (fixed or open), and to explore whether this varies across COPD sub populations defined by exacerbation risk
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects initiated with Tiotropium and Olodaterol (Tio+Olo) |
| ||
| Subjets initiated with LABA/LAMA/ICS | Long-acting beta2/ Long-acting muscarinic antagonists/Inhaled corticosteriods |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium and Olodaterol (Tio+Olo) | Drug | drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrence of a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation). | From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry. |
| Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry | Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation excluding participants who had exacerbation within 30 days prior to cohort entry, was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrenceof a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation). | From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia) | Overall incidence rate of first hospitalization for community-acquired pneumonia (serious pneumonia). | From cohort entry (index date) until the occurrence of hospitalization for community-acquired pneumonia (serious pneumonia). Up to 1 year after cohort entry. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with COPD inititated with Tio+Olo in comparison to patients treated with ICS/LABA/LAMA
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthCore, Inc. | Andover | Massachusetts | 01810 | United States |
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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, except for the following exclusions:
For more details refer to: https://www.mystudywindow.com/msw/datasharing
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The study was conducted using existing administrative healthcare claims and laboratory result data captured in the HealthCore Integrated Research Database (HIRD). The observation period was from January 2013 until the most recent date available at the time that the cohort is extracted (March 2019).
The study investigate the effectiveness and safety of maintenance treatment with combination of tiotropium and olodaterol comparing to maintenance treatment with combination of inhaled corticosteroids in patients with chronic obstructive pulmonary disease (COPD) based on existing data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tiotropium+Olodaterol | All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Tiotropium+Olodaterol (Tio + Olo) treatment from 1 January 2013 until 31 March 2019. |
| FG001 | LABA/LAMA/ICS |
| 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 | Dec 12, 2019 |
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| Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS) | Drug | drug |
|
All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Long-acting beta2-agonist (LABA) / Long-acting muscarinic antagonists (LAMA) / Inhaled corticosteroids (ICS) treatment from 1 January 2013 until 31 March 2019. |
| COMPLETED |
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| NOT COMPLETED |
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Patients with Chronic Obstructive Pulmonary Disease (COPD) from HealthCore Integrated Research Database (January 2013 - March 2019) that meet all inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tiotropium+Olodaterol | All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Tiotropium+Olodaterol (Tio + Olo) treatment from 1 January 2013 until 31 March 2019. |
| BG001 | LABA/LAMA/ICS | All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Long-acting beta2-agonist (LABA) / Long-acting muscarinic antagonists (LAMA) / Inhaled corticosteroids (ICS) treatment from 1 January 2013 until 31 March 2019. |
| BG002 | Total | Total of all reporting groups |
| 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 | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrence of a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation). | Patients with Chronic Obstructive Pulmonary Disease (COPD) from HealthCore Integrated Research Database (January 2013 - March 2019) that meet all inclusion criteria, with laboratory result data available and non-missing endpoint outcomes. | Posted | Number | 95% Confidence Interval | Events per 1000 person-days | From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry. |
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| Secondary | Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia) | Overall incidence rate of first hospitalization for community-acquired pneumonia (serious pneumonia). | Patients with Chronic Obstructive Pulmonary Disease (COPD) from HealthCore Integrated Research Database (January 2013 - March 2019) that meet all inclusion criteria, with laboratory result data available and non-missing endpoint outcomes. | Posted | Number | 95% Confidence Interval | Events per 1000 person-days | From cohort entry (index date) until the occurrence of hospitalization for community-acquired pneumonia (serious pneumonia). Up to 1 year after cohort entry. |
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| Primary | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry | Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation excluding participants who had exacerbation within 30 days prior to cohort entry, was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrenceof a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation). | Patients with Chronic Obstructive Pulmonary Disease (COPD) from HealthCore Integrated Research Database (January 2013 - March 2019) that meet all inclusion criteria, and non-missing endpoint outcomes. Participants with exacerbation within 30 days prior to cohort entry were excluded. | Posted | Number | 95% Confidence Interval | Events per 1000 person-days | From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry. |
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Adverse event information was not applicable for this study.
As this is a non-interventional study with secondary use of data retrieved from HealthCore Integrated Research Database (HIRD) database, safety monitoring and safety reporting on an individual case level is not applicable. Total number of participants at risk is 0 since adverse events were not planned to be collected and reported for this study.
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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 | Tiotropium+Olodaterol | All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Tiotropium+Olodaterol (Tio + Olo) treatment from 1 January 2013 until 31 March 2019. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | LABA/LAMA/ICS | All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Long-acting beta2-agonist (LABA) / Long-acting muscarinic antagonists (LAMA) / Inhaled corticosteroids (ICS) treatment from 1 January 2013 until 31 March 2019. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Oct 28, 2020 |
| 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 |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| C549647 | olodaterol |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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| Units | Counts |
|---|---|
| Participants |
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All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Long-acting beta2-agonist (LABA) / Long-acting muscarinic antagonists (LAMA) / Inhaled corticosteroids (ICS) treatment from 1 January 2013 until 31 March 2019. |
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