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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01634152
Registration number
NCT01634152
Ethics application status
Date submitted
3/07/2012
Date registered
6/07/2012
Date last updated
29/01/2016
Titles & IDs
Public title
Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent Asthma
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Scientific title
A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial 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 as add-on Controller Therapy on Top of Usual Care in Children (6 to 11 Years Old) With Severe Persistent Asthma
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Secondary ID [1]
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2011-001777-43
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Secondary ID [2]
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205.446
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Tiotropium low dose mcg
Treatment: Drugs - Tiotropium high dose
Placebo Comparator: Placebo QD -
Experimental: Tiotropium low dose QD -
Experimental: Tiotropium medium dose QD -
Treatment: Drugs: Placebo
2 actuations once daily in the evening
Treatment: Drugs: Tiotropium low dose mcg
2 actuations once daily in the evening
Treatment: Drugs: Tiotropium high dose
2 actuations once daily in the evening
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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FEV1 Peak(0-3h) Change From Baseline
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and 12 weeks
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Secondary outcome [1]
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Trough FEV1 Change From Baseline
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and 12 weeks
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Secondary outcome [2]
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FVC Peak(0-3h) Change From Baseline
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline and 12 weeks
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Secondary outcome [3]
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Trough FVC Change From Baseline
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Assessment method [3]
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Change from baseline in Trough (pre-dose) FVC measured at week 12.
Measured values presented are actually adjusted means.
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Timepoint [3]
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Baseline and 12 weeks
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Secondary outcome [4]
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FEV1 AUC (0-3h) Change From Baseline
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks
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Secondary outcome [5]
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FVC AUC (0-3h) Change From Baseline
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks
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Secondary outcome [6]
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FEV1 Change From Baseline at Each Individual Timepoint
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Assessment method [6]
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Forced expiratory volume in one second (FEV1) change from baseline at each individual timepoint.
The measured values presented are actually adjusted means.
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Timepoint [6]
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Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks
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Secondary outcome [7]
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FVC Change From Baseline at Each Individual Timepoint
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Assessment method [7]
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FVC change from baseline at each individual timepoint.
The measured values presented are actually adjusted means.
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Timepoint [7]
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Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks
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Secondary outcome [8]
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Control of Asthma as Assessed by ACQ-IA Total Score
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline and 12 weeks
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Secondary outcome [9]
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ACQ-IA Total Score Responders
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Assessment method [9]
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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.
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Timepoint [9]
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12 weeks
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Secondary outcome [10]
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Use of PRN Rescue Medication Per Day
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline and 12 weeks
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Secondary outcome [11]
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Use of PRN Rescue Medication During the Daytime
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline and 12 weeks
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Secondary outcome [12]
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Use of PRN Rescue Medication During the Night-time
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Assessment method [12]
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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 means
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Timepoint [12]
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Baseline and 12 weeks
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Secondary outcome [13]
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Peak Expiratory Flow (PEF) a.m. Change From Baseline
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline and 12 weeks
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Secondary outcome [14]
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Peak Expiratory Flow (PEF) p.m. Change From Baseline
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline and 12 weeks
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Secondary outcome [15]
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Peak Expiratory Flow (PEF) Variability Change From Baseline
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Assessment method [15]
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Change from baseline in the peak expiratory flow variability based on the weekly mean at week 12.
Measured values presented are actually adjusted means.
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Timepoint [15]
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Baseline and 12 weeks
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Secondary outcome [16]
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FEV1 a.m. Change From Baseline
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Assessment method [16]
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Change from baseline in morning (a.m.) FEV1 based on the weekly mean at week 12.
Measured values presented are actually adjusted means.
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Timepoint [16]
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Baseline and 12 weeks
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Secondary outcome [17]
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FEV1 p.m. Change From Baseline
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Assessment method [17]
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Change from baseline in evening (p.m.) FEV1 based on the weekly mean at week 12.
Measured values presented are actually adjusted means.
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Timepoint [17]
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Baseline and 12 weeks
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Secondary outcome [18]
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Change From Baseline in Nighttime Awakenings
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Assessment method [18]
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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.
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Timepoint [18]
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Baseline and 12 weeks
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Secondary outcome [19]
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Change From Baseline in Morning Asthma Symptoms
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Assessment method [19]
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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.
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Timepoint [19]
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Baseline and 12 weeks
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Secondary outcome [20]
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Change From Baseline in Daytime Asthma Symptoms
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Assessment method [20]
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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.
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Timepoint [20]
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Baseline and 12 weeks
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Secondary outcome [21]
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Change From Baseline in Daytime Activity Limitations
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Assessment method [21]
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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.
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Timepoint [21]
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Baseline and 12 weeks
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Secondary outcome [22]
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Change From Baseline in Daytime Experiences of Shortness of Breath
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Assessment method [22]
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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.
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Timepoint [22]
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Baseline and 12 weeks
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Secondary outcome [23]
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Change From Baseline in Daytime Experiences of Wheeze or Cough
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Assessment method [23]
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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.
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Timepoint [23]
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Baseline and 12 weeks
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Secondary outcome [24]
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Change From Baseline in Asthma Symptom-free Days
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Assessment method [24]
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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.
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Timepoint [24]
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Baseline and 12 weeks
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Eligibility
Key inclusion criteria
Inclusion criteria:
Inclusion criteria are:
1. All patients' parent(s) (or legal guardian) must sign and date an informed consent
prior to participation in the trial. In addition, an informed assent suitable for this
age group has to be obtained from patients. A separate informed consent/assent is
required for pharmacogenomic sampling.
2. Male or female patients between 6 and 11 years of age.
3. All patients must have at least a 6-month history of asthma.
4. All patients must have been on maintenance treatment with an inhaled corticosteroid
either at stable high dose in combination with another controller medication, OR at
stable medium dose in combination with two other controller medications, for at least
4 weeks before Visit 1.
5. All patients must be symptomatic (partly controlled) at Visit 1 and prior to
randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ-IA) mean
score >= 1.5.
6. All patients must have a pre-bronchodilator forced expiratory volume in one second
(FEV1) >= 60% and <= 90% of predicted normal at Visit 1.
7. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator, considered as 100%)
as compared to Visit 2 (pre-dose) must be within ± 30%.
8. All patients must confirm the diagnosis of asthma by bronchodilator reversibility at
Visit 1, resulting in an increase in FEV1 of >= 12% 15 to 30 minutes after 200 mcg
salbutamol/albuterol.
9. Patients must be able to use the Respimat inhaler correctly.
10. Patients must be able to perform all trial related procedures including technically
acceptable pulmonary function tests and use of electronic diary/peak flow meter (diary
compliance of at least 80% is required).
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Minimum age
6
Years
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Maximum age
11
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
Exclusion criteria are:
1. Patients with a significant disease other than asthma.
2. Patients with a clinically relevant abnormal haematology or blood chemistry at
screening.
3. Patients with a history of congenital or acquired heart disease, or patients who have
been hospitalised for cardiac syncope or failure during the past year.
4. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac
arrhythmia requiring intervention or a change in drug therapy within the past year.
5. Patients with a malignancy for which the patient has undergone resection, radiation
therapy or chemotherapy within the last five years.
6. Patients with known active tuberculosis.
7. Patients who have undergone thoracotomy with pulmonary resection.
8. Patients who are currently in a pulmonary rehabilitation program or have completed a
pulmonary rehabilitation program in the six weeks prior to Visit 1.
9. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other
components of the inhalation solution used with the Respimat inhaler.
10. Pregnant or nursing female patients, including postmenarchal girls with a positive
urine pregnancy test at Visit 1.
11. Postmenarchal girls of child-bearing potential not using a highly effective method of
birth control.
12. Patients who have been treated with systemic corticosteroids within four weeks prior
to Visit 1.
13. Patients who have been treated with systemic beta-adrenergics within four weeks prior
to Visit 1.
14. Patients who have been treated with oral beta-blocker medication within four weeks
prior to Visit 1 and/or during the screening period.
15. Patients who have been treated with inhaled long-acting anticholinergics or systemic
anticholinergic treatment within four weeks prior to Visit 1 and/or during the
screening period, or who have been treated with inhaled short-acting anticholinergics
within two weeks prior to Visit 1.
16. Patients who have been treated with short-acting theophylline preparations within two
weeks prior to Visit 1.
17. Patients who have been treated with non-approved and according to international
guidelines not recommended experimental drugs for routine asthma therapy within four
weeks prior to Visit 1 and/or during the screening period.
18. Patients who have taken an investigational drug within six half lives according to the
investigator's information, or four weeks (whichever is greater) prior to Visit 1
and/or during the screening period.
19. Patients who have previously been randomised in this trial or are currently
participating in another trial.
20. Patients with any acute asthma exacerbation or respiratory tract infection in the four
weeks prior to Visit 1 and/or in the four weeks prior to Visit 2. In case of an asthma
deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks
prior to Visit 2, the visit must be postponed.
21. Patients requiring six or more puffs of rescue medication per day on more than two
consecutive days in the four weeks prior to Visit 1 and/or in the four weeks prior to
Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit
1 and/or in the four weeks prior to Visit 2, the visit must be postponed.
22. Patients who are unable to comply with medication restrictions prior to Visit 1 and/or
prior to Visit 2.
23. Patients with a known narrow-angle glaucoma, or any other disease where
anticholinergic treatment is contraindicated.
24. Patients with moderate to severe renal impairment, as defined by a creatinine
clearance <50 mL/min/1.73 m2 BSA, as tiotropium is a predominantly renally excreted
drug.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2015
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Sample size
Target
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Accrual to date
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Final
401
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Recruitment in Australia
Recruitment state(s)
QLD,WA
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Recruitment hospital [1]
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205.446.61003 Boehringer Ingelheim Investigational Site - Herston
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Recruitment hospital [2]
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205.446.61001 Boehringer Ingelheim Investigational Site - Perth
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Recruitment postcode(s) [1]
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- Herston
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Recruitment postcode(s) [2]
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- Perth
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Recruitment outside Australia
Country [1]
0
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United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Colorado
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Massachusetts
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Missouri
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Ohio
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Oklahoma
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Country [7]
0
0
United States of America
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State/province [7]
0
0
South Carolina
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Texas
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Country [9]
0
0
Argentina
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State/province [9]
0
0
Buenos Aires
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Country [10]
0
0
Argentina
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State/province [10]
0
0
Capital Federal
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Country [11]
0
0
Argentina
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State/province [11]
0
0
Mar del Plata
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Country [12]
0
0
Argentina
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State/province [12]
0
0
Mendoza
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Country [13]
0
0
Argentina
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State/province [13]
0
0
San Miguel de Tucuman
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Country [14]
0
0
Belgium
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State/province [14]
0
0
Antwerpen
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Country [15]
0
0
Belgium
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State/province [15]
0
0
Brugge
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Country [16]
0
0
Belgium
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State/province [16]
0
0
Namur
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Country [17]
0
0
Brazil
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State/province [17]
0
0
Curitiba
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Country [18]
0
0
Brazil
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State/province [18]
0
0
Goiânia
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Country [19]
0
0
Brazil
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State/province [19]
0
0
Porto Alegre
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Country [20]
0
0
Brazil
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State/province [20]
0
0
Sao Paulo
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Country [21]
0
0
Canada
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State/province [21]
0
0
Ontario
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Country [22]
0
0
Canada
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State/province [22]
0
0
Quebec
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Country [23]
0
0
Czech Republic
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State/province [23]
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0
Jablonec nad Nisou
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Country [24]
0
0
Czech Republic
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State/province [24]
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0
Jihlava
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Country [25]
0
0
Czech Republic
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State/province [25]
0
0
Prague
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Country [26]
0
0
Germany
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State/province [26]
0
0
Berlin
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Country [27]
0
0
Germany
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State/province [27]
0
0
Bochum
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Country [28]
0
0
Germany
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State/province [28]
0
0
Dresden
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Country [29]
0
0
Germany
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State/province [29]
0
0
Frankfurt
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Country [30]
0
0
Germany
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State/province [30]
0
0
Koblenz
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Country [31]
0
0
Germany
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State/province [31]
0
0
Marburg
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Country [32]
0
0
Germany
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State/province [32]
0
0
Mönchengladbach
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Country [33]
0
0
Guatemala
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State/province [33]
0
0
Guatemala
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Country [34]
0
0
Hungary
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State/province [34]
0
0
Ajka
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Country [35]
0
0
Hungary
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State/province [35]
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0
Budapest
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Country [36]
0
0
Hungary
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State/province [36]
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0
Nagyatad
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Country [37]
0
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Hungary
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State/province [37]
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Szeged
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Country [38]
0
0
Latvia
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State/province [38]
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Baldone
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Country [39]
0
0
Latvia
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State/province [39]
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0
Balvi
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Country [40]
0
0
Latvia
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State/province [40]
0
0
Daugavpils
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Country [41]
0
0
Latvia
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State/province [41]
0
0
Jekabpils
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Country [42]
0
0
Latvia
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State/province [42]
0
0
Ogre
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Country [43]
0
0
Latvia
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State/province [43]
0
0
Rezekne
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Country [44]
0
0
Latvia
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State/province [44]
0
0
Riga
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Country [45]
0
0
Lithuania
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State/province [45]
0
0
Siauliai
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Country [46]
0
0
Lithuania
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State/province [46]
0
0
Taurage
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Country [47]
0
0
Lithuania
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State/province [47]
0
0
Utena
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Country [48]
0
0
Lithuania
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State/province [48]
0
0
Vilnius
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Country [49]
0
0
Poland
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State/province [49]
0
0
Bialystok
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Tarnow
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Romania
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Bucharest
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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St. Petersburg
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Russian Federation
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Yaroslavl
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Slovakia
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Kosice
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Slovakia
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Presov
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Slovakia
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Spisska Nova Ves
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Ukraine
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Chernivtsi
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Country [62]
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Ukraine
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Dnipropetrovsk
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Country [63]
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Ukraine
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Donetsk
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Ukraine
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Kharkiv
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Ukraine
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Kiev
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Country [66]
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Ukraine
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Kriviy Rig
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Ukraine
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Lviv
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Country [68]
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Ukraine
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Odesa
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Country [69]
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Ukraine
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State/province [69]
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Vinnytsya
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Ukraine
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Zaporizhya
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Ukraine
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Zaporizhzhya
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Other collaborator category [1]
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Commercial sector/Industry
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Pfizer
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01634152
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Public notes
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Contacts
Principal investigator
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Boehringer Ingelheim
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Boehringer Ingelheim
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01634152
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