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

Organon and Co62 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Asthma, Exercise-Induced

Interventions

Comparator: MontelukastDRUG

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

Comparator: PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 15 YearsMax age: 45 Years

Medical Language ↔ Plain English

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)

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.

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

Secondary Outcomes

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

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

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

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.

Time frame: 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

Data from ClinicalTrials.gov

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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.

Time frame: 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.

Time frame: 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.

Time frame: Pre-exercise baseline measurement and 0-60 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

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

Time frame: 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.

Time frame: Exercise challenge at 2 hours postdose

Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose

Time frame: Exercise challenge at 12 hours postdose

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

Time frame: Exercise challenge at 24 hours postdose