A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety Over 48 Weeks of Orally Inhaled Tiotropium Bromide (2.5 and 5 µg Once Daily ) Delivered by the Respimat® Inhaler in Adolescents (12 to 17 Years Old) With Moderate Persistent Asthma.
Overview
- Phase
- Phase 3
- Intervention
- placebo Respimat
- Conditions
- Asthma
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 398
- Locations
- 66
- Primary Endpoint
- FEV1 peak0-3 Change From Baseline
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses of tiotropium bromide compared to placebo in adolescent patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring lung function parameters and evaluating the effects on asthma exacerbations, on Quality of life, on health care resource utilisation an on the number of adverse events.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
placebo
once daily, delivered with Respimat inhaler
Intervention: placebo Respimat
tiotropium low dose
once daily, delivered with Respimat inhaler
Intervention: tiotropium Respimat low dose
tiotropium high dose
once daily, delivered with Respimat inhaler
Intervention: tiotropium Respimat high dose
Outcomes
Primary Outcomes
FEV1 peak0-3 Change From Baseline
Time Frame: Baseline and 24 weeks
Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak0-3) measured at week 24. Note, the measured values presented are actually adjusted means.
Secondary Outcomes
- Trough FEV1 Change From Baseline(Baseline and 24 weeks)
- FVC peak0-3 Change From Baseline(Baseline and 24 weeks)
- Trough FVC Change From Baseline(Baseline and 24 weeks)
- FEV1 AUC (0-3h) Change From Baseline(Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks)
- FVC AUC (0-3h) Change From Baseline(Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks)
- FEF25-75 Change From Baseline(Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks)
- Use of PRN Rescue Medication During the Daytime(Baseline and Week 24)
- Use of PRN Rescue Medication During the Night-time(Baseline and week 24)
- Use of PRN Rescue Medication During the Day(Baseline and week 24)
- Control of Asthma as Assessed by ACQ Total Score(Baseline and week 24)
- ACQ Total Score Responders(Week 24)
- Control of Asthma as Assessed by ACQ6(Baseline and week 24)
- ACQ6 Responders(Week 24)
- Time to First Severe Asthma Exacerbation During the 48 Week Treatment Period(48 weeks)
- Time to First Asthma Exacerbation During the 48 Week Treatment Period(Week 48)