Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the persistence in using two different medications from the same drug class (LAMA/LABA FDC) which are delivered through different devices, a dry-powder inhalers (DPI) and Soft Mist Inhalers (SMI).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Chronic obstructive pulmonary disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olodaterol/Tiotropium Bromide | Drug | (Stiolto®) delivered via Respimat inhaler |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Discontinuation of Index Treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol) | The primary outcome of interest was discontinuation of index treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol), defined as persistence, (i.e. no refill Claim within 60 days [not including treatment Switch, nor death] after end of supply) during follow-up. Persistence was assessed by calculating rates of discontinuation in the matched cohorts using a 60-day allowable gap. Rates of discontinuation are reported as the number of events divided by the number of Person-years at risk. Addition of another treatment to index treatment did not count as discontinuation. | From first day after the cohort entry date to the earliest occurence of the outcome (discontinuation or refills), or any censoring criteria (365 days of follow-up without discontinuation, death, disenrollment end of data). |
Not provided
Not provided
Inclusion Criteria:
-
Exclusion Criteria:
Not provided
Not provided
Patients initiating Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol up to 2.5 years
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aetion Inc. | New York | New York | 10018 | United States |
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
Not provided
Not provided
Not provided
Not provided
Only subjects that met all inclusion and none of the exclusion criteria were included in the study. Initiators of Olodaterol/Tiotropium Bromide were matched to patients receiving Umeclidinium/Vilanterol using a 1:2 propensity score matching, resulting in a matched cohort of 11296 overall.
The study compared the treatment persistence of patients with Chronic Obstructive Pulmonary Disease (COPD) using Olodaterol/Tiotropium Bromide inhaled via Respimat soft mist inhaler (SMI) versus patients with COPD using Umeclidinium/Vilanterol inhaled via the Ellipta Dry powder inhaler (DPI).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Olodaterol/Tiotropium Bromide - Matched Cohort | Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Olodaterol/Tiotropium Bromide (Stiolto®) delivered with the Respimat soft mist inhaler (SMI), within the Truven MarketScan database between November 2015 and March 2018. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| 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 | Nov 22, 2019 |
Not provided
Not provided
Not provided
Not provided
| Umeclidinium/ Vilanterol | Drug | (Anoro®) delivered via Ellipta Inhaler |
|
| Umeclidinium/Vilanterol - Matched Cohort |
Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Umeclidinium/Vilanterol (Anoro®) delivered with the Ellipta dry powder Inhaler (DPI), within Truven MarketScan database between November 2015 and March 2018. |
| COMPLETED |
|
| NOT COMPLETED |
|
1:2 propensity score matched cohort of initators of Olodaterol/Tiotropium Bromide and Initiators of Umeclidinium/Vilanterol, identified from Truven MarketScan Claims database between November 2015 and March 2018.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Olodaterol/Tiotropium Bromide - Matched Cohort | Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Olodaterol/Tiotropium Bromide (Stiolto®) delivered with the Respimat soft mist inhaler (SMI), within the Truven MarketScan database between November 2015 and March 2018. |
| BG001 | Umeclidinium/Vilanterol - Matched Cohort | Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Umeclidinium/Vilanterol (Anoro®) delivered with the Ellipta dry powder Inhaler (DPI), within Truven MarketScan database between November 2015 and March 2018. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| 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 |
|
| 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 | Rate of Discontinuation of Index Treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol) | The primary outcome of interest was discontinuation of index treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol), defined as persistence, (i.e. no refill Claim within 60 days [not including treatment Switch, nor death] after end of supply) during follow-up. Persistence was assessed by calculating rates of discontinuation in the matched cohorts using a 60-day allowable gap. Rates of discontinuation are reported as the number of events divided by the number of Person-years at risk. Addition of another treatment to index treatment did not count as discontinuation. | 1:2 propensity score matched cohort of initiators of Olodaterol/Tiotropium Bromide and initiators of Umeclidinium/Vilanterol, identified from Truven MarketScan Claims database between November 2015 and March 2018. | Posted | Number | Events per 1000 person-years | From first day after the cohort entry date to the earliest occurence of the outcome (discontinuation or refills), or any censoring criteria (365 days of follow-up without discontinuation, death, disenrollment end of data). |
|
|
|
|
Not provided
As this is a non-interventional study with secondary use of data retrieved from a US health claims database, safety monitoring and safety reporting on an individual case level is not applicable.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olodaterol/Tiotropium Bromide - Matched Cohort | Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Olodaterol/Tiotropium Bromide (Stiolto®) delivered with the Respimat soft mist inhaler (SMI), within the Truven MarketScan database between November 2015 and March 2018. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Umeclidinium/Vilanterol - Matched Cohort | Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Umeclidinium/Vilanterol (Anoro®) delivered with the Ellipta dry powder Inhaler (DPI), within Truven MarketScan database between November 2015 and March 2018. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
By using data from insurance claims, data are based on a large, non-random convenience sample, which may contain biases or lack generalizability to other populations.
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 |
| Jul 2, 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C549647 | olodaterol |
| D000069447 | Tiotropium Bromide |
| C573971 | GSK573719 |
| C550468 | vilanterol |
| 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 |
Not provided
Not provided
|
|