A Study to Evaluate Efficacy and Safety of Tiotropium in Children 6 to 11 Years Old With Moderate Asthma

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Tiotropium bromide

• 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

Study Timeline

• Study First Submitted: 2011-06-20
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Study Start: 2011-08
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2013-09-23
• Results First Submitted QC: 2013-12-04
• Results First Posted: 2013-12-30
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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