Impact of Tiotropium Add-on Therapy in Patients With Asthma

Completed

• Conditions: Asthma
• Interventions: Drug: Tiotropium Respimat®; Drug: Inhaled Corticosteroid/Long-acting beta-agonist

• Registration Number: NCT03964220
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-15
• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-28
• Primary Completion: 2019-09-20
• Study Completion: 2019-09-20
• Results First Submitted: 2020-09-17
• Results First Submitted QC: 2020-09-17
• Status Verified: 2020-10
• Results First Posted: 2020-10-12
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7857

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Asthma	Tiotropium Respimat®	-
Patients with Asthma	Inhaled Corticosteroid/Long-acting beta-agonist	-

Primary Outcome Measures

Name	Time	Method
Time to First Exacerbation	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 Outcome Measures

Name	Time	Method
Rate of Exacerbation at 6 Months and 1 Year of Follow-up	At 6 month and 1 year of follow-up	Exacerbation rate per 100 person-years. Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group).
Health Care Resource Utilization (HCRU) During Follow-up	During follow-up period, From baseline until end of follow-up, up to 3 years	Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group) and up to 3 years of study period.
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	Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group) and up to 3 years of study period. FEV1 score range from 0 to 100. Higher FEV1 score suggests normal lung function, while lower for dangerous. Only the descriptive statistics of FEV1 score were reported other than change of FEV1 score from baseline due to lack of enough data points.
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	Follow-up period was from index date (date of the first prescription for Tiotropium Respimat® 1.25 mcg in Tio group; date of the first prescription from low to medium/high does or medium to high does or additional high-does of Inhaled Corticosteroid (ICS)/long-acting beta-agonists (LABA) for NonTio group) and up to 3 years of study period. ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms not under control. Only the descriptive statistics of ACT score were reported other than change of ACT score from baseline due to lack of enough data points.

Trial Locations

Locations (1)

eMax Health; 🇺🇸 White Plains, New York, United States