Exacerbation Risk in Asthma
1 other identifier
observational
1,899
1 country
1
Brief Summary
The purpose of this study is to conduct a comparative analysis of patients using Tiotropium in combination with Inhaled Corticosteroids (ICS) versus those that use long-acting β2-agonists (LABA) medication in combination with ICS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2021
CompletedFirst Submitted
Initial submission to the registry
August 12, 2022
CompletedFirst Posted
Study publicly available on registry
August 15, 2022
CompletedResults Posted
Study results publicly available
April 1, 2024
CompletedApril 1, 2024
October 1, 2023
6 months
August 12, 2022
October 27, 2022
October 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Time to First Severe Exacerbation
Severe exacerbation defined as: * Hospitalization with primary diagnosis of asthma or * Emergency room (ER) visit with primary diagnosis of asthma The analysis of this endpoint is based on number of observations (exacerbations). Index date is defined as date when patient entered the cohort. Design 1: A time-varying covariate approach to classify drug exposure time for each comparator drug during follow up was used. For each individual study drug, medication exposure + non-exposure windows during the follow-up time for each medication were identified/defined using date of prescription filled + days' supply listed on prescription claim + 50% additional days.
From index date to first severe exacerbation, up to 1 year.
Secondary Outcomes (6)
Time to First Moderate-or-severe Exacerbation
From index date to first moderate-or-severe exacerbation, up to 1 year.
Percentage of Patients With Exacerbation
From index date through first report of exacerbation, up to 1 year.
Rate of Exacerbation at 6 Months and One Year
at 6 months and one year
Percentage of Patients With Health Care Resource Utilization (HCRU)
From index date to end of follow-up, up to 1 year.
Health Care Resource Utilization (HCRU)
From index date to end of follow-up, up to 1 year.
- +1 more secondary outcomes
Study Arms (2)
tiotropium + inhaled corticosteroids (ICS) group
long-acting β2-agonists (LABA) + inhaled corticosteroids (ICS) group
Interventions
long-acting β2-agonists (LABA)
inhaled corticosteroids (ICS)
Eligibility Criteria
Patients with least two asthma diagnosis will be included. Patients will be required to have enrollment for at least 6 months prior to ICS+Tio or ICS/LABA use.
You may qualify if:
- Patients with least two asthma diagnosis
- Patients will be required to be concurrently on inhaled corticosteroids (ICS)+Tiotropium (tio) (specifically Tiotropium Respimat® 1.25 mcg) or ICS/LABA
- Patients will be required to have enrollment for at least 6 months prior to ICS+Tio or ICS/LABA use
You may not qualify if:
- Patients with least two diagnosis of chronic obstructive pulmonary disease (COPD) at any time during the study period
- Patients less than 12 years of age
- Patients on biologics within 6 months prior to ICS+Tio or ICS/LABA use
- Patients with prior Tio or ICS/LABA use during the 6-month baseline period
- Patients with urinary bladder obstruction, urinary retention, and glaucoma
- After the propensity score matching (PSM) process, unmatched patients
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)
Intervention 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
August 12, 2022
First Posted
August 15, 2022
Study Start
May 14, 2021
Primary Completion
November 2, 2021
Study Completion
November 2, 2021
Last Updated
April 1, 2024
Results First Posted
April 1, 2024
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share
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