Montelukast in Exercise-Induced Bronchospasm - 2004 (0476-275)(COMPLETED)

Overview[ - collapse ][ - ]

Purpose The purpose of this study is 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.
ConditionAsthma, Exercise-Induced
InterventionDrug: Comparator: Montelukast
Drug: Comparator: Placebo
PhasePhase 3
SponsorMerck Sharp & Dohme Corp.
Responsible PartyMerck Sharp & Dohme Corp.
ClinicalTrials.gov IdentifierNCT00090142
First ReceivedAugust 24, 2004
Last UpdatedSeptember 18, 2013
Last verifiedSeptember 2013

Tracking Information[ + expand ][ + ]

First Received DateAugust 24, 2004
Last Updated DateSeptember 18, 2013
Start DateMay 2004
Estimated Primary Completion DateOctober 2004
Current Primary Outcome MeasuresMaximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Post-dose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) [Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose] [Designated as safety issue: No]In patients with EIB, the percent change from pre-exercise baseline FEV, 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.
Current Secondary Outcome Measures
  • Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose [Time Frame: 0-90 minutes after the exercise challenge performed at 2 hours postdose] [Designated as safety issue: No]
  • Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose [Time Frame: 0-90 minutes after the exercise challenge performed at 12 hours postdose] [Designated as safety issue: No]
  • Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose [Time Frame: 0-90 minutes after the exercise challenge performed at 24 hours postdose] [Designated as safety issue: No]
  • Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB [Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose] [Designated as safety issue: No]In patients with EIB, the percent change from pre-exercise baseline FEV, 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.
  • Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB [Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose] [Designated as safety issue: No]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 [Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose] [Designated as safety issue: No]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 12 Hours Postdose [Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose] [Designated as safety issue: No]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 0-60min) at 24 Hours Postdose [Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose] [Designated as safety issue: No]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 [Time Frame: Exercise challenge at 2 hours postdose] [Designated as safety issue: No]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 12 Hours Postdose [Time Frame: Exercise challenge at 12 hours postdose] [Designated as safety issue: No]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 [Time Frame: Exercise challenge at 24 hours postdose] [Designated as safety issue: No]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.

Descriptive Information[ + expand ][ + ]

Brief TitleMontelukast in Exercise-Induced Bronchospasm - 2004 (0476-275)(COMPLETED)
Official TitleA Double-Blind, Randomized, Placebo-Controlled, Multicenter, 2-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast on Exercise-Induced Bronchospasm
Brief Summary
The purpose of this study is 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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
ConditionAsthma, Exercise-Induced
InterventionDrug: Comparator: Montelukast
Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge
Drug: Comparator: Placebo
Placebo tablet administered orally as a single witnessed dose before exercise challenge
Study Arm (s)
  • Experimental: 1
    Montelukast - Placebo
  • Experimental: 2
    Placebo - Montelukast

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment62
Estimated Completion DateOctober 2004
Estimated Primary Completion DateOctober 2004
Eligibility Criteria
Inclusion Criteria:

- Patients with mild-to-moderate asthma

Exclusion Criteria:

- Medical history of a lung disorder (other than asthma) or a recent upper respiratory
tract infection

- 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
GenderBoth
Ages15 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00090142
Other Study ID Numbers0476-275
Has Data Monitoring CommitteeNo
Information Provided ByMerck Sharp & Dohme Corp.
Study SponsorMerck Sharp & Dohme Corp.
CollaboratorsNot Provided
Investigators Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Verification DateSeptember 2013