Impact of Tiotropium Add-on Therapy in Patients With Asthma
The Effectiveness of Tiotropium Add-on Therapy Using a Real-world Cohort of Patients With Asthma
1 other identifier
observational
7,857
1 country
1
Brief Summary
To evaluate the effectiveness of add on therapy with Tiotropium Respimat® compared to increasing the dose of ICS in patients with a diagnosis of Asthma and on ICS/LABA therapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2019
CompletedFirst Submitted
Initial submission to the registry
May 24, 2019
CompletedFirst Posted
Study publicly available on registry
May 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2019
CompletedResults Posted
Study results publicly available
October 12, 2020
CompletedNovember 3, 2020
October 1, 2020
6 months
May 24, 2019
September 17, 2020
October 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Time to First Exacerbation
Exacerbations will be defined as either a hospitalization with a primary diagnosis of asthma, an emergency room (ER) visit with a primary diagnosis of asthma, an asthma exacerbation diagnosis recorded.
From baseline until end of follow-up, up to 3 years
Secondary Outcomes (4)
Rate of Exacerbation at 6 Months and 1 Year of Follow-up
At 6 month and 1 year of follow-up
Health Care Resource Utilization (HCRU) During Follow-up
During follow-up period, From baseline until end of follow-up, up to 3 years
Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1) Score) at Baseline and Follow up Period
From baseline until end of follow-up, up to 3 years
Change in Asthma Control Test (ACT) Score at Baseline and in the Follow up Period
From baseline until end of follow-up, up to 3 years
Study Arms (1)
Patients with Asthma
Interventions
Tiotropium Respimat® 1.25 mcg (on top of baseline Inhaled Corticosteroid/Long-acting beta-agonist )
baseline low dose to medium/high dose, baseline medium dose ICS/LABA to high dose ICS/LABA, additional prescription/refill of high-dose-ICS/LABA following the first prescription of baseline high dose ICS/LABA
Eligibility Criteria
Asthmatics 6 years and above on ICS/LABA at baselineIMS Pharmetrics (IMS or Database I); EMRClaims+ (Database II)
You may qualify if:
- Patients with least one asthma diagnosis in the inpatient setting or at least two separate instances of asthma diagnosis (separated by at least 30 days) recorded in the outpatient or emergency room setting will be included.
- Patients will be required to be already on Inhaled Corticosteroid/Long-acting beta-agonist (ICS/LABA).
- Patients will be required to have available records 12 months prior to the index date.
You may not qualify if:
- Patients below the age of 6 years on the Inhaled Corticosteroid/Long-acting beta-agonist initiation (ICS/LABAi) date will be excluded.
- Patients with a diagnosis of COPD at any time during the study period will be excluded.
- Those who are on biologics at baseline will be removed.
- After the PSM process, unmatched patients will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
eMax Health
White Plains, New York, 10601, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2019
First Posted
May 28, 2019
Study Start
March 15, 2019
Primary Completion
September 20, 2019
Study Completion
September 20, 2019
Last Updated
November 3, 2020
Results First Posted
October 12, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial\_results/ clinical\_submission\_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.