Clinical Trials Directory

Trials / Completed

CompletedNCT00092131

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

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
51 (actual)
Sponsor
Organon and Co · Industry
Sex
All
Age
15 Years – 45 Years
Healthy volunteers
Not accepted

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 participants who have a history of worsening asthma after exercise.

Conditions

Interventions

TypeNameDescription
DRUGComparator: MontelukastMontelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge
DRUGComparator: PlaceboPlacebo tablet administered orally as a single witnessed dose before exercise challenge

Timeline

Start date
2003-06-01
Primary completion
2003-11-01
Completion
2003-11-01
First posted
2004-09-24
Last updated
2022-02-02
Results posted
2010-06-17

Source: ClinicalTrials.gov record NCT00092131. Inclusion in this directory is not an endorsement.