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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
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma, Exercise-Induced

Eligibility Criteria

15 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 26, 2005
    Last Updated
    January 31, 2022
    Sponsor
    Organon and Co
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    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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