A Study to Evaluate Efficacy and Safety of Tiotropium in Children 6 to 11 Years Old With Moderate Asthma
- Registration Number
- NCT01383499
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment A Tiotropium bromide patients inhale 2 puffs (low dose) once daily in the evening via Respimat inhaler Treatment D Tiotropium bromide patients inhale 2 puffs of placebo inhalation solution matching tiotropium once daily in the evening via Respimat inhaler Treatment B Tiotropium bromide patients inhale 2 puffs (medium dose) once daily in the evening via Respimat inhaler Treatment C Tiotropium bromide patients inhale 2 puffs (high dose) once daily in the evening via Respimat inhaler
- Primary Outcome Measures
Name Time Method Forced Expiratory Volume (FEV1) Peak (0-3h) Response 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 Outcome Measures
Name Time Method Trough FEV1 Response Baseline and 4 weeks The trough FEV1 is defined as the pre-dose FEV1 measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Forced Vital Capacity (FVC) Peak (0-3h) Response Baseline and 4 weeks The FVC peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FVC measured within the first 3 hours post dosing and the FVC baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
FVC Trough Response Baseline and 4 weeks The trough FVC response is defined as the pre-dose FVC measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response Baseline and 4 weeks FEV1 (AUC0-3h) will be calculated as the area under the curve from 0 to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response Baseline and 4 weeks FVC (AUC0-3h) will be calculated as the area under the curve from 0 to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Mean Morning Peak Expiratory Flow (PEF) Response Baseline and 4 weeks Mean morning PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Mean Evening PEF Response Baseline and 4 weeks Mean Evening PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Change From Baseline in the Number of Puffs of Rescue Medication Per Period (24 h, Daytime and Night-time Use) Baseline and 4 weeks Mean number of inhalations (puffs) of unscheduled rescue salbutamol therapy during whole day (24 h, daytime and night-time use). Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Control of Asthma as Assessed by Asthma Control Questionnaire (ACQ) 4 weeks ACQ is a questionnaire consisting of seven point Likert scale ranging from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The scale describes the frequency and severity of asthma symptoms. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Change From Baseline in Mean Number of Nighttime Awakenings Baseline and last week of treatment (week 4) Mean number of nighttime awakenings due to asthma symptoms as assessed by patients eDiary incorporated in the AM3® device. Analysis adjusted for treatment, period, patient and baseline using a mixed model. The scores for this question used the following scale where: 1='Did not wake up', 2='Woke up once', 3='Woke up 2-5 times', 4='Woke up more than 5 times' and 5='Was awake all night'.
Trial Locations
- Locations (24)
205.425.49005 Boehringer Ingelheim Investigational Site
🇩🇪Bochum, Germany
205.425.49004 Boehringer Ingelheim Investigational Site
🇩🇪Dresden, Germany
205.425.36002 Boehringer Ingelheim Investigational Site
🇭🇺Mosdos, Hungary
205.425.36003 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
205.425.49002 Boehringer Ingelheim Investigational Site
🇩🇪Koblenz, Germany
205.425.37101 Boehringer Ingelheim Investigational Site
🇱🇻Baldone, Latvia
205.425.36001 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
205.425.36004 Boehringer Ingelheim Investigational Site
🇭🇺Szeged, Hungary
205.425.37104 Boehringer Ingelheim Investigational Site
🇱🇻Daugavpils, Latvia
205.425.37106 Boehringer Ingelheim Investigational Site
🇱🇻Dubulti, Latvia
205.425.37001 Boehringer Ingelheim Investigational Site
🇱🇹Vilnius, Lithuania
205.425.07001 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
205.425.38003 Boehringer Ingelheim Investigational Site
🇺🇦Zaporizhya, Ukraine
205.425.37002 Boehringer Ingelheim Investigational Site
🇱🇹Vilnius, Lithuania
205.425.37003 Boehringer Ingelheim Investigational Site
🇱🇹Taurage, Lithuania
205.425.38002 Boehringer Ingelheim Investigational Site
🇺🇦Donetsk, Ukraine
205.425.07002 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
205.425.37105 Boehringer Ingelheim Investigational Site
🇱🇻Balvi, Latvia
205.425.37102 Boehringer Ingelheim Investigational Site
🇱🇻Riga, Latvia
205.425.37103 Boehringer Ingelheim Investigational Site
🇱🇻Riga, Latvia
205.425.07003 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
205.425.37004 Boehringer Ingelheim Investigational Site
🇱🇹Kaunas, Lithuania
205.425.38004 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
205.425.07004 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation