A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 ug and 5 ug Once Daily) Compared to Placebo Over 12 Weeks in Mild Persistent Asthma
Overview
- Phase
- Phase 3
- Intervention
- tiotropium 5 mcg
- Conditions
- Asthma
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 465
- Locations
- 62
- Primary Endpoint
- Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium compared to placebo over 12 week treatment period. Tiotropium inhalation solution will be delivered via Respimat inhaler and will be examined on top of maintenance inhaled corticosteroid treatment in patients with mild persistent asthma. Efficacy and safety will be assessed by measuring the effects on lung functions, effects on lung exacerbations, effects on asthma control and numbers of adverse events.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
tiotropium 5 mcg
once daily delivered via Respimat inhaler
Intervention: tiotropium 5 mcg
tiotropium 2.5 mcg
once daily delivered via Respimat inhaler
Intervention: tiotropium 2.5 mcg
placebo
once daily delivered via Respimat inhaler
Intervention: placebo
Outcomes
Primary Outcomes
Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks.
Time Frame: Baseline and 12 weeks
Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.
Secondary Outcomes
- Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 12-week Treatment Period.(Baseline and 12 weeks)
- FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 12-week Treatment Period.(Baseline and 12 weeks)
- FVC (AUC0-3h) Response at the End of the 12-week Treatment Period.(Baseline and 12 weeks)
- Asthma Control Questionnaire (ACQ) Responder After 12 Weeks of Treatment(12 weeks)
- Time to First Severe Asthma Exacerbation During the 12-week Treatment.(12 weeks)
- Time to First Asthma Exacerbation During the 12-week Treatment.(12 weeks)
- Trough FEV1 Response Determined After a Treatment Period of 12 Weeks.(Baseline and 12 weeks)
- Use of Rescue Medication During 24h Period(Baseline and 12 weeks)
- Use of Rescue Medication During Daytime(Baseline and 12 weeks)
- Use of Rescue Medication During Nighttime(Baseline and 12 weeks)