A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 mcg and 5 mcg Once Daily) Over 12 Weeks as add-on Controller Therapy on Top of Usual Care in Adolescents (12 to 17 Years Old) With Severe Persistent Asthma
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 392
- Locations
- 69
- Primary Endpoint
- FEV1 peak0-3 Change From Baseline
Study Overview
Brief Summary
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma.
The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary function endpoint after 12 weeks of treatment.
Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints, and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy on top of usual care in this patient population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 12 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
A
Intervention: tiotropium low dose (Drug)
B
Intervention: tiotropium high dose (Drug)
C
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
FEV1 peak0-3 Change From Baseline
Time Frame: Baseline and 12 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 12. Measured values presented are actually adjusted means.
Secondary Outcomes
- Trough FEV1 Change From Baseline(Baseline and 12 weeks)
- FVC peak0-3 Change From Baseline(Baseline and 12 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 12 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 12 weeks)
- Control of Asthma as Assessed by ACQ6 Score.(Baseline and 12 weeks)
- ACQ6 Score Responders(12 weeks)
- Control of Asthma as Assessed by ACQ Total Score(Baseline and 12 weeks)
- ACQ Total Score Responders(12 weeks)
- Use of PRN Rescue Medication During the Day(Baseline and 12 weeks)
- Use of PRN Rescue Medication During the Daytime(Baseline and 12 weeks)
- Use of PRN Rescue Medication During the Night-time(Baseline and 12 weeks)
- Time to First Severe Asthma Exacerbation During the 12-week Treatment Period.(12 weeks)
- Analysis of Time to First Asthma Exacerbation During the 12 Week Treatment Period.(12 weeks)
- Clinically Relevant Abnormalities for Physical Examination, ECG, Vital Signs and Laboratory Tests(From first drug administration until 30 days after last drug intake, up to 142 days)