Skip to main content
OpenTrials
Completed

NCT Number: NCT00245570

Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma, Exercise-Induced Asthma Bronchial Diseases Exercise-Induced Allergies Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

15 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comparator: montelukast

Drug

1 dose montelukast 10 mg tablet given orally in one of three treatment periods

Comparator: Salmeterol

Drug

1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods

Comparator: Placebo (montelukast)

Drug

1 dose matching-image placebo to montelukast tablet in two of three treatment periods

Comparator: Placebo (salmeterol)

Drug

1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods

Primary outcomes

  1. 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)

    Time frame: 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose

    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 outcomes

  1. 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

  2. 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

  3. 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

  4. Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB

    Time frame: 0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose

    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.

  5. Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB

    Time frame: 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose

    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.

  6. 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: 0-60 minutes after the exercise challenge at 2 hours postdose

    The measure included only the area below the pre-exercise

    baseline

  7. 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

    Time frame: 0-60 minutes after the exercise challenge at 8.5 hours postdose

    The measure included only the area below the pre-exercise baseline

  8. 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

    Time frame: 0-60 minutes after the exercise challenge at 24 hours postdose

    The measure included only the area below the pre-exercise baseline

  9. Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose

    Time frame: 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.

  10. Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose

    Time frame: 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.

  11. Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 28, 2005
Registry last updated
Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.