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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma, Exercise-Induced
• Intervention / Treatment: Drug: Comparator: Montelukast; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Montelukast - Placebo	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
Experimental: 2; Placebo - Montelukast	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The measure included only the area below the pre-exercise baseline.	Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose
Time to Recovery From Maximum Percentage Decrease in FEV1 After 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.	Exercise challenge at 2 hours postdose
Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose		0-90 minutes after the exercise challenge performed at 2 hours postdose
Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose		0-90 minutes after the exercise challenge performed at 12 hours postdose
Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose		0-90 minutes after the exercise challenge performed at 24 hours postdose
Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB	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.	Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose
Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB	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.	Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose
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	The measure included only the area below the pre-exercise baseline.	Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose
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	The measure included only the area below the pre-exercise baseline.	Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose
Time to Recovery From Maximum Percentage Decrease in FEV1 After 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.	Exercise challenge at 12 hours postdose
Time to Recovery From Maximum Percentage Decrease in FEV1 After 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.	Exercise challenge at 24 hours postdose

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Philip G, Villaran C, Pearlman DS, Loeys T, Dass SB, Reiss TF. Protection against exercise-induced bronchoconstriction two hours after a single oral dose of montelukast. J Asthma. 2007 Apr;44(3):213-7. doi: 10.1080/02770900701209806.

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Primary Completion (Actual): October 1, 2004
• Study Completion (Actual): October 1, 2004

Study Registration Dates

• First Submitted: August 24, 2004
• First Submitted That Met QC Criteria: August 25, 2004
• First Posted (Estimate): August 26, 2004

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Bronchial Spasm; Asthma, Exercise-Induced; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: 0476-275; 2004_009