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

Phase 3

Completed

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

• Registration Number: NCT01277523
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma.

The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary function endpoint after 12 weeks of treatment.

Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints, and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy on top of usual care in this patient population.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-13
• Study First Posted: 2011-01-17
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-10
• Results First Submitted: 2014-10-14
• Results First Submitted QC: 2014-10-14
• Last Update Submitted: 2014-10-14
• Results First Posted: 2014-10-20
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	tiotropium high dose	-
C	placebo	-
A	tiotropium low dose	-

Primary Outcome Measures

Name	Time	Method
FEV1 peak0-3 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 peak0-3) 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 peak0-3 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 peak0-3h) after 12 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 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 AUC0-3h) 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.
Control of Asthma as Assessed by ACQ6 Score.	Baseline and 12 weeks	Change from baseline in Asthma Control Questionnaire (ACQ) 6 score measured at week 12; 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. ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ6.; The measured values presented are actually adjusted means.
ACQ6 Score Responders	12 weeks	Responder rates based on the ACQ6 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).; 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. ACQ6 is calculated as the mean of the responses to the first 6 questions of the ACQ6.; No statistical testing was performed on ACQ6 responders.
Control of Asthma as Assessed by ACQ Total Score	Baseline and 12 weeks	Change from baseline in Asthma Control Questionnaire (ACQ) total score measured at week 12.; 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 is calculated as the mean of the responses to all 7 questions.; The measured values presented are actually adjusted means.
ACQ Total Score Responders	12 weeks	Responder rates based on the ACQ 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 total score responders.; 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.
Use of PRN Rescue Medication During the Day	Baseline and 12 weeks	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 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 means
Time to First Severe Asthma Exacerbation During the 12-week Treatment Period.	12 weeks	Time in days to first severe asthma exacerbation during the 12 week treatment period. 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 an initiation of treatment with systemic corticosteroids for at least 3 days or, in case of ongoing and pre-existing systemic corticosteroid therapy, requiring at least doubling of previous daily doses of systemic corticosteroids for at least 3 days.
Analysis of Time to First Asthma Exacerbation During the 12 Week Treatment Period.	12 weeks	Time in days to first asthma exacerbation during the 12 week treatment period. 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.
Clinically Relevant Abnormalities for Physical Examination, ECG, Vital Signs and Laboratory Tests	From first drug administration until 30 days after last drug intake, up to 142 days	Clinically relevant abnormalities for physical examination, ECG, vital signs and laboratory tests. New abnormal findings or worsening of baseline conditions were reported as adverse events.

Trial Locations

Locations (69)

205.456.01004 Boehringer Ingelheim Investigational Site; 🇺🇸 Stockton, California, United States

205.456.01008 Boehringer Ingelheim Investigational Site; 🇺🇸 Normal, Illinois, United States

205.456.01003 Boehringer Ingelheim Investigational Site; 🇺🇸 Baltimore, Maryland, United States

205.456.01007 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbia, Missouri, United States

205.456.01002 Boehringer Ingelheim Investigational Site; 🇺🇸 Bellevue, Nebraska, United States

205.456.01001 Boehringer Ingelheim Investigational Site; 🇺🇸 Rockville Centre, New York, United States

205.456.01005 Boehringer Ingelheim Investigational Site; 🇺🇸 Cincinnati, Ohio, United States

205.456.01006 Boehringer Ingelheim Investigational Site; 🇺🇸 Summerville, South Carolina, United States

205.456.54002 Boehringer Ingelheim Investigational Site; 🇦🇷 Capital Federal, Argentina

205.456.54006 Boehringer Ingelheim Investigational Site; 🇦🇷 Capital Federal, Argentina

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