A Phase II Randomised, Double-blind, Placebo-controlled Incomplete Crossover Trial With 4-week Treatment Periods to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (Doses of 1.25 µg, 2.5 µg and 5 µg) Delivered Via Respimat® Inhaler Once Daily in the Evening in Children 6 to 11 Yrs Old With Moderate Persistent Asthma
Overview
- Phase
- Phase 2
- Intervention
- Tiotropium bromide
- Conditions
- Asthma
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 101
- Locations
- 24
- Primary Endpoint
- Forced Expiratory Volume (FEV1) Peak (0-3h) Response
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The aim of this trial is to select an optimum dose may be selected based on bronchodilator efficacy, safety evaluations and pharmacokinetics of tiotropium bromide.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment A
patients inhale 2 puffs (low dose) once daily in the evening via Respimat inhaler
Intervention: Tiotropium bromide
Treatment B
patients inhale 2 puffs (medium dose) once daily in the evening via Respimat inhaler
Intervention: Tiotropium bromide
Treatment C
patients inhale 2 puffs (high dose) once daily in the evening via Respimat inhaler
Intervention: Tiotropium bromide
Treatment D
patients inhale 2 puffs of placebo inhalation solution matching tiotropium once daily in the evening via Respimat inhaler
Intervention: Tiotropium bromide
Outcomes
Primary Outcomes
Forced Expiratory Volume (FEV1) Peak (0-3h) Response
Time Frame: Baseline and 4 weeks
The FEV1 peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Secondary Outcomes
- Trough FEV1 Response(Baseline and 4 weeks)
- Forced Vital Capacity (FVC) Peak (0-3h) Response(Baseline and 4 weeks)
- FVC Trough Response(Baseline and 4 weeks)
- FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response(Baseline and 4 weeks)
- FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response(Baseline and 4 weeks)
- Mean Morning Peak Expiratory Flow (PEF) Response(Baseline and 4 weeks)
- Mean Evening PEF Response(Baseline and 4 weeks)
- Change From Baseline in the Number of Puffs of Rescue Medication Per Period (24 h, Daytime and Night-time Use)(Baseline and 4 weeks)
- Control of Asthma as Assessed by Asthma Control Questionnaire (ACQ)(4 weeks)
- Change From Baseline in Mean Number of Nighttime Awakenings(Baseline and last week of treatment (week 4))