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Montelukast in Exercise-Induced Bronchospasm - 2003 (0476-270)

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ClinicalTrials.gov Identifier: NCT00092131
Recruitment Status : Completed
First Posted : September 24, 2004
Results First Posted : June 17, 2010
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Asthma, Exercise-Induced
Interventions Drug: Comparator: Montelukast
Drug: Comparator: Placebo
Enrollment 51
Recruitment Details

Patients were randomized at 9 sites.

Primary therapy period: July to November 2003

Pre-assignment Details Patients who required excluded medications, or did not meet forced expiratory volume in 1 second (FEV1) criteria during the prestudy period were excluded from randomization. Patients who required a β-agonist after the exercise challenge and did not meet FEV1 criteria within 30 minutes of treatment were also excluded.
Arm/Group Title Montelukast 10 mg in Period I Then Placebo in Period II Placebo in Period I Then Montelukast 10 mg in Period II
Hide Arm/Group Description A montelukast 10-mg tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast matching-image placebo tablet (Treatment Period II) was taken orally as a single witnessed dose. A montelukast matching-image placebo tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast 10-mg tablet (Treatment Period II) was taken orally as a single witnessed dose.
Period Title: Treatment Period I
Started 25 [1] 26
Completed 24 26
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
[1]
1 patient discontinued due to influenza which started in washout (11 days after Period I medication)
Period Title: Treatment Period II
Started 24 26 [1]
Completed 24 25
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
[1]
1 patient discontinued after taking Period II study medication, due to asthma exacerbation
Arm/Group Title Overall Study Population
Hide Arm/Group Description All randomized patients
Overall Number of Baseline Participants 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants
24.5  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
27
  52.9%
Male
24
  47.1%
Need for β-agonist rescue medication following exercise challenge  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants
No 47
Yes 4
AUC for percent change from pre-exercise measurement FEV1 in L 0-60 mins after exercise challenge   [1] 
Mean (Standard Deviation)
Unit of measure:  (percent change) *minutes
Number Analyzed 51 participants
762.59  (380.34)
[1]
Measure Description:

Area under the curve (AUC) for FEV1 percent change from pre-exercise

measurement over the first hour after exercise challenge.

Maximum Percent Fall in forced expiratory volume in 1 second (FEV1) post-exercise challenge   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent change from pre-exercise measure
Number Analyzed 51 participants
27.63  (5.60)
[1]
Measure Description: Maximum percent fall in FEV1 from pre-exercise measurement occurring within the first 60 minutes after exercise challenge. Pre-exercise measurement FEV1 is the value (in liters) measured on the day of the exercise challenge, 5 minutes before exercise testing.
Time to recovery from maximal percent fall in FEV1 after exercise challenge   [1] 
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 51 participants
45.15  (29.70)
[1]
Measure Description: The duration between the time at which the maximum percent fall in FEV1 occurs and the time when the FEV1 returns to within 5% of the pre-exercise measurement for the first time after the exercise challenge
1.Primary Outcome
Title Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)
Hide Description In Participants with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
Time Frame Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.
Arm/Group Title Placebo Montelukast 10 mg
Hide Arm/Group Description:
All Placebo patients from Treatment Periods I and II
All Montelukast 10 mg patients from Treatment Periods I and II
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: Percent Change
22.33  (13.10) 10.80  (7.88)
2.Secondary Outcome
Title Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose
Hide Description [Not Specified]
Time Frame 0-90 minutes after the exercise challenge performed at 2 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.
Arm/Group Title Placebo Montelukast 10 mg
Hide Arm/Group Description:
All Placebo patients from Treatment Periods I and II
All Montelukast 10 mg patients from Treatment Periods I and II
Overall Number of Participants Analyzed 49 49
Measure Type: Number
Unit of Measure: Participants
Number of Patients Requiring Rescue Medication 7 1
Number of Patients Not Requiring Rescue Medication 42 48
3.Secondary Outcome
Title Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose
Hide Description [Not Specified]
Time Frame 0-90 minutes after the exercise challenge performed at 12 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.
Arm/Group Title Placebo Montelukast 10 mg
Hide Arm/Group Description:
All Placebo patients from Treatment Periods I and II
All Montelukast 10 mg patients from Treatment Periods I and II
Overall Number of Participants Analyzed 48 48
Measure Type: Number
Unit of Measure: Participants
Number of Patients Requiring Rescue Medication 5 1
Number of Patients Not Requiring Rescue Medication 43 47
4.Secondary Outcome
Title Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose
Hide Description [Not Specified]
Time Frame 0-90 minutes after the exercise challenge performed at 24 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.
Arm/Group Title Placebo Montelukast 10 mg
Hide Arm/Group Description:
All Placebo patients from Treatment Periods I and II
All Montelukast 10 mg patients from Treatment Periods I and II
Overall Number of Participants Analyzed 46 46
Measure Type: Number
Unit of Measure: Participants
Number of Patients Requiring Rescue Medication 3 1
Number of Patients Not Requiring Rescue Medication 43 45
5.Secondary Outcome
Title Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)
Hide Description In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (12 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
Time Frame Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.
Arm/Group Title Placebo Montelukast 10 mg
Hide Arm/Group Description:
All Placebo patients from Treatment Periods I and II
All Montelukast 10 mg patients from Treatment Periods I and II
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: Percent Change
16.12  (10.23) 8.35  (7.50)
6.Secondary Outcome
Title Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)
Hide Description In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
Time Frame Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.
Arm/Group Title Placebo Montelukast 10 mg
Hide Arm/Group Description:
All Placebo patients from Treatment Periods I and II
All Montelukast 10 mg patients from Treatment Periods I and II
Overall Number of Participants Analyzed 46 46
Mean (Standard Deviation)
Unit of Measure: Percent Change
16.86  (11.69) 8.33  (7.34)
7.Secondary Outcome
Title Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 2 Hours Postdose
Hide Description The measure included only the area below the pre-exercise baseline.
Time Frame Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.
Arm/Group Title Placebo Montelukast 10 mg
Hide Arm/Group Description:
All Placebo patients from Treatment Periods I and II
All Montelukast 10 mg patients from Treatment Periods I and II
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: (percent change) *minutes
702.13  (674.98) 182.46  (235.94)
8.Secondary Outcome
Title Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 12 Hours Postdose
Hide Description The measure included only the area below the pre-exercise baseline.
Time Frame Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.
Arm/Group Title Placebo Montelukast 10 mg
Hide Arm/Group Description:
All Placebo patients from Treatment Periods I and II
All Montelukast 10 mg patients from Treatment Periods I and II
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: (percent change) *minutes
389.55  (317.09) 152.27  (179.49)
9.Secondary Outcome
Title Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose
Hide Description The measure included only the area below the pre-exercise baseline.
Time Frame Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.
Arm/Group Title Placebo Montelukast 10 mg
Hide Arm/Group Description:
All Placebo patients from Treatment Periods I and II
All Montelukast 10 mg patients from Treatment Periods I and II
Overall Number of Participants Analyzed 46 46
Mean (Standard Deviation)
Unit of Measure: (percent change) *minutes
409.50  (426.55) 120.06  (119.77)
10.Secondary Outcome
Title Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose
Hide Description The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Time Frame Exercise challenge at 2 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.
Arm/Group Title Placebo Montelukast 10 mg
Hide Arm/Group Description:
All Placebo patients from Treatment Periods I and II
All Montelukast 10 mg patients from Treatment Periods I and II
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: Minutes
37.67  (32.44) 10.82  (16.43)
11.Secondary Outcome
Title Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose
Hide Description The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Time Frame Exercise challenge at 12 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.
Arm/Group Title Placebo Montelukast 10 mg
Hide Arm/Group Description:
All Placebo patients from Treatment Periods I and II
All Montelukast 10 mg patients from Treatment Periods I and II
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: Minutes
24.50  (25.71) 7.97  (12.68)
12.Secondary Outcome
Title Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose
Hide Description The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Time Frame Exercise challenge at 24 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.
Arm/Group Title Placebo Montelukast 10 mg
Hide Arm/Group Description:
All Placebo patients from Treatment Periods I and II
All Montelukast 10 mg patients from Treatment Periods I and II
Overall Number of Participants Analyzed 46 46
Mean (Standard Deviation)
Unit of Measure: Minutes
23.14  (26.13) 5.74  (8.36)
Time Frame During Period I and II (2 day treatment periods) and the 3 to 7 day crossover washout period, and up to and including 14 days after the last dose of study therapy.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Montelukast 10 mg in Period I Then Placebo in Period II Placebo in Period I Then Montelukast 10 mg in Period II
Hide Arm/Group Description A montelukast 10-mg tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast matching-image placebo tablet (Treatment Period II) was taken orally as a single witnessed dose. A montelukast matching-image placebo tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast 10-mg tablet (Treatment Period II) was taken orally as a single witnessed dose.
All-Cause Mortality
Montelukast 10 mg in Period I Then Placebo in Period II Placebo in Period I Then Montelukast 10 mg in Period II
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Montelukast 10 mg in Period I Then Placebo in Period II Placebo in Period I Then Montelukast 10 mg in Period II
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Montelukast 10 mg in Period I Then Placebo in Period II Placebo in Period I Then Montelukast 10 mg in Period II
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/26 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092131     History of Changes
Other Study ID Numbers: 0476-270
MK0476-270
2004_026
First Submitted: September 21, 2004
First Posted: September 24, 2004
Results First Submitted: September 24, 2009
Results First Posted: June 17, 2010
Last Update Posted: July 15, 2015