The Effectiveness of Tiotropium Add-on Therapy Using a Real-world Cohort of Patients With Asthma

Boehringer Ingelheim1 site in 1 country7,857 target enrollmentMarch 15, 2019

ConditionsAsthma

InterventionsTiotropium Respimat®Inhaled Corticosteroid/Long-acting beta-agonist

DrugsTiotropium Respimat®Inhaled Corticosteroid/Long-acting beta-agonist

Overview

Phase: Not Applicable
Intervention: Tiotropium Respimat®
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Enrollment: 7857
Locations: 1
Primary Endpoint: Time to First Exacerbation
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 15, 2019

End Date

September 20, 2019

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Arms & Interventions

Patients with Asthma

Intervention: Tiotropium Respimat®

Patients with Asthma

Intervention: Inhaled Corticosteroid/Long-acting beta-agonist

Outcomes

Primary Outcomes

Time to First Exacerbation

Time Frame: From baseline until end of follow-up, up to 3 years

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.

Secondary Outcomes

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)