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. |
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Condition | Asthma, Exercise-Induced |
Intervention | Drug: Comparator: Montelukast Drug: Comparator: Placebo |
Phase | Phase 3 |
Sponsor | Merck Sharp & Dohme Corp. |
Responsible Party | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier | NCT00090142 |
First Received | August 24, 2004 |
Last Updated | September 18, 2013 |
Last verified | September 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | August 24, 2004 |
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Last Updated Date | September 18, 2013 |
Start Date | May 2004 |
Estimated Primary Completion Date | October 2004 |
Current Primary Outcome Measures | Maximum 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 |
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Descriptive Information[ + expand ][ + ]
Brief Title | Montelukast in Exercise-Induced Bronchospasm - 2004 (0476-275)(COMPLETED) |
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Official Title | A 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 Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention |
Condition | Asthma, Exercise-Induced |
Intervention | Drug: 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) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 62 |
Estimated Completion Date | October 2004 |
Estimated Primary Completion Date | October 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 |
Gender | Both |
Ages | 15 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00090142 |
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Other Study ID Numbers | 0476-275 |
Has Data Monitoring Committee | No |
Information Provided By | Merck Sharp & Dohme Corp. |
Study Sponsor | Merck Sharp & Dohme Corp. |
Collaborators | Not Provided |
Investigators | Study Director: Medical Monitor Merck Sharp & Dohme Corp. |
Verification Date | September 2013 |