A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Safety and Efficacy of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo Over 52 Weeks in Patients With Moderate to Severe Persistent Asthma
Overview
- Phase
- Phase 3
- Intervention
- Tiotropium Respimat
- Conditions
- Asthma
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 285
- Locations
- 55
- Primary Endpoint
- Number of Patients With Drug-related Adverse Events
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over a 52-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate to severe persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on asthma control, and number of adverse events.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Tiotropium Respimat (low dose)
Tiotropium low dose once daily delivered with Respimat inhaler
Intervention: Tiotropium Respimat
Tiotropium Respimat (high dose)
Tiotropium high dose once daily delivered with Respimat inhaler
Intervention: Tiotropium Respimat
Placebo Respimat
Tiotropium placebo once daily delivered with Respimat inhaler
Intervention: Placebo Respimat
Outcomes
Primary Outcomes
Number of Patients With Drug-related Adverse Events
Time Frame: after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409
The primary endpoint is the number of patients with drug-related adverse events
Secondary Outcomes
- Weekly Mean Number of Puffs of Rescue Medication During the Whole Day (Response)(baseline and week 52)
- Trough FEV1 Response(baseline and week 52)
- Trough PEF Response(baseline and week 52)
- Trough FVC Response(baseline and week 52)
- Weekly Mean PEFpm Response(baseline and week 52)
- Weekly Mean Score of Asthma Symptoms During the Day (Response)(baseline and week 52)
- Weekly Mean Score of Asthma Symptoms in the Morning (Response)(baseline and week 52)
- Weekly Mean PEFam Response(baseline and week 52)
- Weekly Mean PEF Variability Response(baseline and week 52)