Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent Asthma
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT01634152
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 401
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo QD Placebo - Tiotropium low dose QD Tiotropium low dose mcg - Tiotropium medium dose QD Tiotropium high dose -
- Primary Outcome Measures
Name Time Method FEV1 Peak(0-3h) Change From Baseline Baseline and 12 weeks Change from baseline in peak forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak(0-3h)) measured at week 12.
Measured values presented are actually adjusted means.
- Secondary Outcome Measures
Name Time Method Trough FEV1 Change From Baseline Baseline and 12 weeks Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.
Measured values presented are actually adjusted means.FVC Peak(0-3h) Change From Baseline Baseline and 12 weeks Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak(0-3h)) after 12 weeks of treatment.
The measured values presented are actually adjusted means.Trough FVC Change From Baseline Baseline and 12 weeks Change from baseline in Trough (pre-dose) FVC measured at week 12.
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 12 weeks Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC (0-3h)) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
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 12 weeks Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC (0-3h)) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
Measured values presented are actually adjusted means.FEV1 Change From Baseline at Each Individual Timepoint Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks Forced expiratory volume in one second (FEV1) change from baseline at each individual timepoint.
The measured values presented are actually adjusted means.FVC Change From Baseline at Each Individual Timepoint Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks FVC change from baseline at each individual timepoint.
The measured values presented are actually adjusted means.Control of Asthma as Assessed by ACQ-IA Total Score Baseline and 12 weeks Change from baseline in Interviewer-Administered Asthma Control Questionnaire (ACQ-IA) total score measured at week 12.
The ACQ-IA 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-IA total score is calculated as the mean of the responses to all 7 questions.
The measured values presented are actually adjusted means.ACQ-IA Total Score Responders 12 weeks Responder categories based on the ACQ-IA total score after 12 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) No statistical testing was performed for ACQ-IA total score responders.
The ACQ-IA 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.Use of PRN Rescue Medication Per Day Baseline and 12 weeks Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used per day (24 hour period) based on the weekly mean at week 12.
The measured values presented are actually adjusted means.Use of PRN Rescue Medication During the Daytime Baseline and 12 weeks Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 12.
Measured values presented are actually adjusted means.Use of PRN Rescue Medication During the Night-time Baseline and 12 weeks 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 12.
Measured values presented are actually adjusted meansPeak Expiratory Flow (PEF) a.m. Change From Baseline Baseline and 12 weeks Change from baseline in the morning (a.m.) peak expiratory flow based on the weekly mean at week 12.
Measured values presented are actually adjusted means.Peak Expiratory Flow (PEF) p.m. Change From Baseline Baseline and 12 weeks Change from baseline in the evening (p.m.) peak expiratory flow based on the weekly mean at week 12.
Measured values presented are actually adjusted means.Peak Expiratory Flow (PEF) Variability Change From Baseline Baseline and 12 weeks Change from baseline in the peak expiratory flow variability based on the weekly mean at week 12.
Measured values presented are actually adjusted means.FEV1 a.m. Change From Baseline Baseline and 12 weeks Change from baseline in morning (a.m.) FEV1 based on the weekly mean at week 12.
Measured values presented are actually adjusted means.FEV1 p.m. Change From Baseline Baseline and 12 weeks Change from baseline in evening (p.m.) FEV1 based on the weekly mean at week 12.
Measured values presented are actually adjusted means.Change From Baseline in Nighttime Awakenings Baseline and 12 weeks Change from baseline in nighttime awakenings based on the weekly mean at week 12.
Nighttime awakenings was assessed by the question "Did you wake up during the night due to your asthma?" from the e-diary. Scores range from 1 (did not wake up) to 5 (was awake all night).
Measured values presented are actually adjusted means.Change From Baseline in Morning Asthma Symptoms Baseline and 12 weeks Change from baseline in morning asthma symptoms based on the weekly mean at week 12.
Morning asthma symptoms was assessed by the question "how were your asthma symptoms this morning?" from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).
Measured values presented are actually adjusted means.Change From Baseline in Daytime Asthma Symptoms Baseline and 12 weeks Change from baseline in daytime asthma symptoms based on the weekly mean at week 12.
Daytime asthma symptoms was assessed by the question "how were your asthma symptoms during the day?" from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).
Measured values presented are actually adjusted means.Change From Baseline in Daytime Activity Limitations Baseline and 12 weeks Change from baseline in daytime activity limitations based on the weekly mean at week 12.
Daytime activity limitations was assessed by the question "how limited were you in your activities today because of your asthma?" from the e-diary. Scores range from 1 (not limited) to 5 (totally limited).
Measured values presented are actually adjusted means.Change From Baseline in Daytime Experiences of Shortness of Breath Baseline and 12 weeks Change from baseline in daytime experiences of shortness of breath based on the weekly mean at week 12.
Daytime experiences of shortness of breath was assessed by the question "how much shortness of breath did you experience during the day" from the e-diary. Scores range from 1 (none) to 5 (a very great deal).
Measured values presented are actually adjusted means.Change From Baseline in Daytime Experiences of Wheeze or Cough Baseline and 12 weeks Change from baseline in daytime experiences of wheeze or cough based on the weekly mean at week 12.
Daytime experiences of wheeze or cough was assessed by the question "did you experience wheeze or cough during the day?" from the e-diary. Scores range from 1 (not at all) to 5 (all the time).
Measured values presented are actually adjusted means.Change From Baseline in Asthma Symptom-free Days Baseline and 12 weeks Change from baseline in asthma symptom-free days based on the weekly mean at week 12.
A day was considered as an asthma symptom-free day if there were no symptoms reported via the e-Diary and no use of rescue medication reported via the eDiary during that day.
Measured values presented are actually adjusted means.
Trial Locations
- Locations (94)
205.446.01014 Boehringer Ingelheim Investigational Site
🇺🇸Rolling Hills Estates, California, United States
205.446.01011 Boehringer Ingelheim Investigational Site
🇺🇸Denver, Colorado, United States
205.446.01003 Boehringer Ingelheim Investigational Site
🇺🇸North Dartmouth, Massachusetts, United States
205.446.01009 Boehringer Ingelheim Investigational Site
🇺🇸Columbia, Missouri, United States
205.446.01005 Boehringer Ingelheim Investigational Site
🇺🇸Cincinnati, Ohio, United States
205.446.01010 Boehringer Ingelheim Investigational Site
🇺🇸Oklahoma City, Oklahoma, United States
205.446.01004 Boehringer Ingelheim Investigational Site
🇺🇸Charleston, South Carolina, United States
205.446.01002 Boehringer Ingelheim Investigational Site
🇺🇸North Charleston, South Carolina, United States
205.446.01012 Boehringer Ingelheim Investigational Site
🇺🇸Arlington, Texas, United States
205.446.01013 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
Scroll for more (84 remaining)205.446.01014 Boehringer Ingelheim Investigational Site🇺🇸Rolling Hills Estates, California, United States