Efficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate Asthma
- Registration Number
- NCT01122680
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25 mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium 5 mcg (2 actuations of 2.5 mcg) once daily in the evening delivered by the Respimat inhaler in adolescents (12 to 17 yrs) with moderate persistent asthma, compared to placebo and on top of maintenance therapy with an inhaled corticosteroid controller medication. It is a randomised, double-blind, placebo-controlled Phase II trial with incomplete cross-over design. Patients need to be still symptomatic, i. e. not fully controlled with their maintenance treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
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 (dose of 1.25 mcg) once daily in the evening via Respimat inhaler Treatment C tiotropium bromide patients inhale 2 puffs (dose of 5 mcg) once daily in the evening via Respimat inhaler Placebo Placebo patients inhale 2 puffs of placebo matching tiotropium once daily in the evening via Respimat inhaler Treatment B tiotropium bromide patients inhale 2 puffs (dose of 2.5 mcg) 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.
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 3hours 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.
FEV1 Individual Measurements Response at Each Time-point Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose) Individual FEV1 measurements at each time-point ("personal best"). 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.
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 3hours 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 Individual Measurements at Each Time-point Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose) Individual FVC measurements at each time-point ("personal best"). Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Forced Expiratory Flow (FEF) 25-75% Individual Measurements Response at Each Time Point Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose) FEF 25-75% is the mean forced expiratory flow between 25% and 75% of the FVC determined at the end of the 4-week treatment period. This is often referred to as the maximum midexpiratory flow. 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 Day Baseline and 4 weeks Mean number of inhalations (puffs) of unscheduled rescue salbutamol therapy during whole day. 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 a 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.
Trial Locations
- Locations (19)
205.424.01006 Boehringer Ingelheim Investigational Site
🇺🇸Columbia, Missouri, United States
205.424.01007 Boehringer Ingelheim Investigational Site
🇺🇸Warrensburg, Missouri, United States
205.424.49004 Boehringer Ingelheim Investigational Site
🇩🇪Rosenheim, Germany
205.424.01002 Boehringer Ingelheim Investigational Site
🇺🇸Denver, Colorado, United States
205.424.01004 Boehringer Ingelheim Investigational Site
🇺🇸Boys Town, Nebraska, United States
205.424.37101 Boehringer Ingelheim Investigational Site
🇱🇻Riga, Latvia
205.424.01001 Boehringer Ingelheim Investigational Site
🇺🇸Canton, Ohio, United States
205.424.37105 Boehringer Ingelheim Investigational Site
🇱🇻Rezekne, Latvia
205.424.37102 Boehringer Ingelheim Investigational Site
🇱🇻Riga, Latvia
205.424.37003 Boehringer Ingelheim Investigational Site
🇱🇹Vilnius, Lithuania
205.424.49002 Boehringer Ingelheim Investigational Site
🇩🇪Wesel, Germany
205.424.49007 Boehringer Ingelheim Investigational Site
🇩🇪Koblenz, Germany
205.424.37104 Boehringer Ingelheim Investigational Site
🇱🇻Balvi, Latvia
205.424.37001 Boehringer Ingelheim Investigational Site
🇱🇹Vilnius, Lithuania
205.424.37004 Boehringer Ingelheim Investigational Site
🇱🇹Vilnius, Lithuania
205.424.38604 Boehringer Ingelheim Investigational Site
🇸🇮Kamnik, Slovenia
205.424.38602 Boehringer Ingelheim Investigational Site
🇸🇮Maribor, Slovenia
205.424.37103 Boehringer Ingelheim Investigational Site
🇱🇻Daugavpils, Latvia
205.424.38605 Boehringer Ingelheim Investigational Site
🇸🇮Ljubljana, Slovenia