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

Organon and Co0 sites62 target enrollmentMay 2004

ConditionsAsthma, Exercise-Induced

DrugsComparator: Montelukast Comparator: Placebo

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Asthma, Exercise-Induced
Sponsor: Organon and Co
Enrollment: 62
Primary Endpoint: 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)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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 patients who have a history of worsening asthma after exercise.

Registry

clinicaltrials.gov

Start Date

May 2004

End Date

October 2004

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

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(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(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(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(Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 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)
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(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(Exercise challenge at 2 hours postdose)
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose(Exercise challenge at 12 hours postdose)
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose(Exercise challenge at 24 hours postdose)