Efficacy and Safety of 2 Doses of Tiotropium Via Respimat Compared to Placebo in Adolescents With Moderate Persistent Asthma

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: tiotropium Respimat low dose; Drug: tiotropium Respimat high dose; Drug: placebo Respimat

• Registration Number: NCT01257230
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses of tiotropium bromide compared to placebo in adolescent patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring lung function parameters and evaluating the effects on asthma exacerbations, on Quality of life, on health care resource utilisation an on the number of adverse events.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2014-06-12
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-07
• Results First Posted: 2014-08-08
• Last Update Submitted: 2014-08-27
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 398

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tiotropium low dose	tiotropium Respimat low dose	once daily, delivered with Respimat inhaler
tiotropium high dose	tiotropium Respimat high dose	once daily, delivered with Respimat inhaler
placebo	placebo Respimat	once daily, delivered with Respimat inhaler

Primary Outcome Measures

Name	Time	Method
FEV1 peak0-3 Change From Baseline	Baseline and 24 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 24.; Note, the measured values presented are actually adjusted means.

Secondary Outcome Measures

Name	Time	Method
Trough FEV1 Change From Baseline	Baseline and 24 weeks	Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 24.; The measured values presented are actually adjusted means.
FVC peak0-3 Change From Baseline	Baseline and 24 weeks	Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 h after administration of trial medication (FVC peak0-3h) after 24 weeks of treatment.; The measured values presented are actually adjusted means.
Trough FVC Change From Baseline	Baseline and 24 weeks	Change from baseline of Trough (pre-dose) forced vital capacity (FVC) measured 10 min before the administration of trial medication after 24 weeks of treatment.; The measured values presented are actually adjusted means..
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 24 weeks	Change from baseline of area under the curve (AUC) from 0 to 3 h for FEV1 (FEV1 AUC 0-3h) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).; The measured values presented are actually adjusted means.
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 24 weeks	Change from baseline of area under the curve (AUC) from 0 to 3 h for FVC (FVC AUC0-3h) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).; The measured values presented are actually adjusted means.
FEF25-75 Change From Baseline	Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks	Change from baseline in mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75%), also known as maximum mid-expiratory flow, at individual time points after 24 weeks of treatment.; The measured values presented are actually adjusted means.
Use of PRN Rescue Medication During the Daytime	Baseline and Week 24	Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 24.; The measured values presented are actually adjusted means.
Use of PRN Rescue Medication During the Night-time	Baseline and week 24	Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 24.; The measured values presented are actually adjusted means.
Use of PRN Rescue Medication During the Day	Baseline and week 24	Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the day (24 hour period) based on the weekly mean at week 24.; The measured values presented are actually adjusted means.
Control of Asthma as Assessed by ACQ Total Score	Baseline and week 24	Change from baseline in Asthma Control Questionnaire (ACQ) total score measured at week 24.; The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ total score was calculated as the mean of the responses to all 7 questions.; The measured values presented are actually adjusted means.
ACQ Total Score Responders	Week 24	Responder rates based on the ACQ total score after 24 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 \<change from trial baseline \<0.5) and worsening (change from trial baseline ≥0.5); The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment.
Control of Asthma as Assessed by ACQ6	Baseline and week 24	Change from baseline in AQC6 score at week 24.; The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment.; The measured values presented are actually adjusted means.
ACQ6 Responders	Week 24	Responder rates based on the ACQ6 after 24 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 \<change from trial baseline \<0.5) and worsening (change from trial baseline ≥0.5); The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment.
Time to First Severe Asthma Exacerbation During the 48 Week Treatment Period	48 weeks	The median time to first severe asthma exacerbation was not calculable, so the number of patients who experienced a severe asthma exacerbation are presented for the measured values. A severe asthma exacerbation was defined as a subgroup of all asthma exacerbations that required treatment with systemic corticosteroid for at least 3 days.
Time to First Asthma Exacerbation During the 48 Week Treatment Period	Week 48	The median time to first asthma exacerbation was not calculable, so the number of patients who experienced an asthma exacerbation are presented for the measured values.

Trial Locations

Locations (66)

205.444.01004 Boehringer Ingelheim Investigational Site; 🇺🇸 Plymouth, Minnesota, United States

205.444.01005 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbia, Missouri, United States

205.444.01001 Boehringer Ingelheim Investigational Site; 🇺🇸 Cincinnati, Ohio, United States

205.444.01014 Boehringer Ingelheim Investigational Site; 🇺🇸 Oklahoma City, Oklahoma, United States

205.444.01002 Boehringer Ingelheim Investigational Site; 🇺🇸 Charleston, South Carolina, United States

205.444.01012 Boehringer Ingelheim Investigational Site; 🇺🇸 Charleston, South Carolina, United States

205.444.01013 Boehringer Ingelheim Investigational Site; 🇺🇸 El Paso, Texas, United States

205.444.01003 Boehringer Ingelheim Investigational Site; 🇺🇸 South Burlington, Vermont, United States

205.444.56002 Boehringer Ingelheim Investigational Site; 🇨🇱 Santiago, Chile

205.444.56001 Boehringer Ingelheim Investigational Site; 🇨🇱 Viña del Mar, Chile

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