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Completed

NCT Number: NCT00090142

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

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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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

  • 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

Treatment and study plan

Comparator: montelukast

Drug

Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge

Comparator: placebo

Drug

Placebo tablet administered orally as a single witnessed dose before exercise challenge

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

    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.

  5. 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

    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: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 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 12 Hours Postdose

    Time frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 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 0-60min) at 24 Hours Postdose

    Time frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 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 12 Hours Postdose

    Time frame: Exercise challenge at 12 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, Placebo-Controlled, Multicenter, 2-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast on Exercise-Induced Bronchospasm

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Aug 26, 2004
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.

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