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

Organon and Co0 sites47 target enrollmentDecember 2005

ConditionsAsthma, Exercise-Induced

DrugsComparator: Montelukast Comparator: Salmeterol Comparator: Placebo (montelukast)Comparator: Placebo (salmeterol)

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Asthma, Exercise-Induced
Sponsor: Organon and Co
Enrollment: 47
Primary Endpoint: 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)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

December 2005

End Date

September 2006

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

•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.

Outcomes

Primary Outcomes

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

Number of Patients Requiring β-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 β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose(0-90 minutes after the exercise challenge performed at 8.5 hours postdose)
Number of Patients Requiring β-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 8.5 Hours Post-dose in Patients With EIB(0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose)
Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB(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(0-60 minutes after the exercise challenge 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 8.5 Hours Postdose(0-60 minutes after the exercise challenge at 8.5 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 24 Hours Postdose(0-60 minutes after the exercise challenge 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 8.5 Hours Postdose(Exercise challenge at 8.5 hours postdose)
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose(Exercise challenge at 24 hours postdose)