Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316)
Primary Purpose
Asthma, Exercise-Induced
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: Montelukast
Comparator: Salmeterol
Comparator: Placebo (montelukast)
Comparator: Placebo (salmeterol)
Sponsored by
About this trial
This is an interventional prevention trial for Asthma, Exercise-Induced
Eligibility Criteria
Inclusion Criteria: Physician-diagnosed exercise-induced bronchospasm Exclusion Criteria: Patient is, other than asthma, not in good, stable health. The Primary Investigator will evaluate whether there are other reasons why the patient may not participate.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
6
Arm Description
Montelukast - Salmeterol - Placebo
Montelukast - Placebo - Salmeterol
Salmeterol - Montelukast - Placebo
Salmeterol - Placebo - Montelukast
Placebo - Montelukast - Salmeterol
Placebo - Salmeterol - Montelukast
Outcomes
Primary Outcome Measures
Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB)
In patients 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.
Secondary Outcome Measures
Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose
Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose
Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose
Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB
In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (8.5 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB
In patients with EIB, the percent change from pre-exercise baseline FEV, 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.
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose
The measure included only the area below the pre-exercise
baseline
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose
The measure included only the area below the pre-exercise baseline
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 24 Hours Postdose
The measure included only the area below the pre-exercise baseline
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose
The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose
The time to recovery from maximum percent fall is the
duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the
time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose
The time to recovery from maximum percent fall is the
duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the
time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00245570
Brief Title
Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316)
Official Title
A Double-Blind, Randomized Multicenter, 3-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast Compared With Placebo and Salmeterol on Exercise-Induced Bronchoconstriction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have a history of worsening asthma after exercise.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Exercise-Induced
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Montelukast - Salmeterol - Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Montelukast - Placebo - Salmeterol
Arm Title
3
Arm Type
Experimental
Arm Description
Salmeterol - Montelukast - Placebo
Arm Title
4
Arm Type
Experimental
Arm Description
Salmeterol - Placebo - Montelukast
Arm Title
5
Arm Type
Experimental
Arm Description
Placebo - Montelukast - Salmeterol
Arm Title
6
Arm Type
Experimental
Arm Description
Placebo - Salmeterol - Montelukast
Intervention Type
Drug
Intervention Name(s)
Comparator: Montelukast
Intervention Description
1 dose montelukast 10 mg tablet given orally in one of three treatment periods
Intervention Type
Drug
Intervention Name(s)
Comparator: Salmeterol
Intervention Description
1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo (montelukast)
Intervention Description
1 dose matching-image placebo to montelukast tablet in two of three treatment periods
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo (salmeterol)
Intervention Description
1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
Primary Outcome Measure Information:
Title
Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB)
Description
In patients 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
0-60 minutes after the exercise challenge performed 2 hours after a single oral dose
Secondary Outcome Measure Information:
Title
Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose
Time Frame
0-90 minutes after the exercise challenge performed at 2 hours postdose
Title
Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose
Time Frame
0-90 minutes after the exercise challenge performed at 8.5 hours postdose
Title
Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose
Time Frame
0-90 minutes after the exercise challenge performed at 24 hours postdose
Title
Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB
Description
In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (8.5 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
0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose
Title
Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB
Description
In patients with EIB, the percent change from pre-exercise baseline FEV, 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
0-60 minutes after the exercise challenge performed 24 hours after a single oral dose
Title
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose
Description
The measure included only the area below the pre-exercise
baseline
Time Frame
0-60 minutes after the exercise challenge at 2 hours postdose
Title
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose
Description
The measure included only the area below the pre-exercise baseline
Time Frame
0-60 minutes after the exercise challenge at 8.5 hours postdose
Title
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 24 Hours Postdose
Description
The measure included only the area below the pre-exercise baseline
Time Frame
0-60 minutes after the exercise challenge at 24 hours postdose
Title
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose
Description
The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge 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
Title
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose
Description
The time to recovery from maximum percent fall is the
duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the
time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Time Frame
Exercise challenge at 8.5 hours postdose
Title
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose
Description
The time to recovery from maximum percent fall is the
duration between the time at which the maximum percent fall in FEV1 after exercise challenge 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Physician-diagnosed exercise-induced bronchospasm
Exclusion Criteria:
Patient is, other than asthma, not in good, stable health. The Primary Investigator will evaluate whether there are other reasons why the patient may not participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17573489
Citation
Philip G, Pearlman DS, Villaran C, Legrand C, Loeys T, Langdon RB, Reiss TF. Single-dose montelukast or salmeterol as protection against exercise-induced bronchoconstriction. Chest. 2007 Sep;132(3):875-83. doi: 10.1378/chest.07-0550. Epub 2007 Jun 15.
Results Reference
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Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316)
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