Efficacy and Safety of 2 Doses of Tiotropium Via Respimat Compared to Placebo in Adolescents With Moderate Persistent Asthma
- Conditions
- Asthma
- Interventions
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 398
Not provided
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)
205.444.01005 Boehringer Ingelheim Investigational Site
🇺🇸Columbia, Missouri, United States
205.444.38004 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
205.444.38010 Boehringer Ingelheim Investigational Site
🇺🇦Zaporizhya, Ukraine
205.444.42104 Boehringer Ingelheim Investigational Site
🇸🇰Kosice, Slovakia
205.444.01004 Boehringer Ingelheim Investigational Site
🇺🇸Plymouth, Minnesota, 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
205.444.01013 Boehringer Ingelheim Investigational Site
🇺🇸El Paso, Texas, United States
205.444.01012 Boehringer Ingelheim Investigational Site
🇺🇸Charleston, South Carolina, United States
205.444.01003 Boehringer Ingelheim Investigational Site
🇺🇸South Burlington, Vermont, United States
205.444.49007 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
205.444.56001 Boehringer Ingelheim Investigational Site
🇨🇱Viña del Mar, Chile
205.444.56003 Boehringer Ingelheim Investigational Site
🇨🇱Viña del Mar, Chile
205.444.49008 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
205.444.49006 Boehringer Ingelheim Investigational Site
🇩🇪Koblenz, Germany
205.444.49005 Boehringer Ingelheim Investigational Site
🇩🇪Rosenheim, Germany
205.444.49001 Boehringer Ingelheim Investigational Site
🇩🇪Bochum, Germany
205.444.49003 Boehringer Ingelheim Investigational Site
🇩🇪Ettenheim, Germany
205.444.36007 Boehringer Ingelheim Investigational Site
🇭🇺Ajka, Hungary
205.444.36005 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
205.444.36008 Boehringer Ingelheim Investigational Site
🇭🇺Budapest, Hungary
205.444.70004 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
205.444.39003 Boehringer Ingelheim Investigational Site
🇮🇹Bolzano, Italy
205.444.36001 Boehringer Ingelheim Investigational Site
🇭🇺Miskolc, Hungary
205.444.37103 Boehringer Ingelheim Investigational Site
🇱🇻Talsi, Latvia
205.444.52002 Boehringer Ingelheim Investigational Site
🇲🇽Guadalajara, Mexico
205.444.36006 Boehringer Ingelheim Investigational Site
🇭🇺Kaposvar, Hungary
205.444.82006 Boehringer Ingelheim Investigational Site
🇰🇷Incheon, Korea, Republic of
205.444.70001 Boehringer Ingelheim Investigational Site
🇷🇺Yaroslavl, Russian Federation
205.444.39001 Boehringer Ingelheim Investigational Site
🇮🇹Ancona, Italy
205.444.39002 Boehringer Ingelheim Investigational Site
🇮🇹Verona, Italy
205.444.70002 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
205.444.82004 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
205.444.36003 Boehringer Ingelheim Investigational Site
🇭🇺Szeged, Hungary
205.444.34008 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
205.444.36004 Boehringer Ingelheim Investigational Site
🇭🇺Szigetbecse, Hungary
205.444.52001 Boehringer Ingelheim Investigational Site
🇲🇽Hermosillo, Mexico
205.444.52003 Boehringer Ingelheim Investigational Site
🇲🇽Monterrey, Mexico
205.444.37105 Boehringer Ingelheim Investigational Site
🇱🇻Rezekne, Latvia
205.444.82001 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
205.444.36002 Boehringer Ingelheim Investigational Site
🇭🇺Mosdos, Hungary
205.444.70005 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
205.444.70006 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
205.444.82003 Boehringer Ingelheim Investigational Site
🇰🇷Guri, Korea, Republic of
205.444.70003 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
205.444.37101 Boehringer Ingelheim Investigational Site
🇱🇻Baldone, Latvia
205.444.37107 Boehringer Ingelheim Investigational Site
🇱🇻Balvi, Latvia
205.444.37102 Boehringer Ingelheim Investigational Site
🇱🇻Ogre, Latvia
205.444.37104 Boehringer Ingelheim Investigational Site
🇱🇻Tukums, Latvia
205.444.34007 Boehringer Ingelheim Investigational Site
🇪🇸Esplugues del Llobregat, Spain
205.444.42106 Boehringer Ingelheim Investigational Site
🇸🇰Martin, Slovakia
205.444.38001 Boehringer Ingelheim Investigational Site
🇺🇦Lviv, Ukraine
205.444.38002 Boehringer Ingelheim Investigational Site
🇺🇦Donetsk, Ukraine
205.444.34001 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
205.444.34006 Boehringer Ingelheim Investigational Site
🇪🇸Sabdadell, Spain
205.444.38005 Boehringer Ingelheim Investigational Site
🇺🇦Kharkiv, Ukraine
205.444.34004 Boehringer Ingelheim Investigational Site
🇪🇸Majadahonda (Madrid), Spain
205.444.38008 Boehringer Ingelheim Investigational Site
🇺🇦Dnipropetrovsk, Ukraine
205.444.38003 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
205.444.34005 Boehringer Ingelheim Investigational Site
🇪🇸Marbella, Spain
205.444.56002 Boehringer Ingelheim Investigational Site
🇨🇱Santiago, Chile
205.444.37106 Boehringer Ingelheim Investigational Site
🇱🇻Riga, Latvia
205.444.42101 Boehringer Ingelheim Investigational Site
🇸🇰Nitra, Slovakia
205.444.42105 Boehringer Ingelheim Investigational Site
🇸🇰Roznava, Slovakia
205.444.38009 Boehringer Ingelheim Investigational Site
🇺🇦Zaporizhzhya, Ukraine