Completed

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

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What is being tested

Comparator: Montelukast

+ Comparator: Placebo

Drug
Who is being recruted

Exercise-Induced Allergies+6

+ Asthma

+ Asthma, Exercise-Induced

From 15 to 45 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorOrganon and Co
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2004

Actual date on which the first participant was enrolled.

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.

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
NCT00090142
Principal SponsorOrganon and Co
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

62 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 15 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Exercise-Induced AllergiesAsthmaAsthma, Exercise-InducedBronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesRespiratory HypersensitivityRespiratory Tract Diseases

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Montelukast - Placebo

Group II

Experimental
Placebo - Montelukast

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers