Montelukast in Exercise-Induced Bronchospasm - 2003 (0476-270)

Phase 3

Completed

• Conditions: Asthma, Exercise-Induced

• Registration Number: NCT00092131
• Lead Sponsor: Organon and Co

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 participants who have a history of worsening asthma after exercise.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2003-11
• Study Completion: 2003-11
• Study First Submitted: 2004-09-21
• Study First Submitted QC: 2004-09-23
• Study First Posted: 2004-09-24
• Results First Submitted: 2009-09-24
• Results First Submitted QC: 2010-05-14
• Results First Posted: 2010-06-17
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Participants with mild-to-moderate asthma

Exclusion Criteria

• Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)	Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose	In Participants 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 Outcome Measures

Name	Time	Method
Number of Participants 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 Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose	0-90 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 0-60min) at 24 Hours Postdose	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.
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose	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 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Number of Participants 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 Exercise-induced Bronchospasm (EIB)	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 FEV1 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.
Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)	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 FEV1 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.
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 2 Hours Postdose	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.
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 12 Hours Postdose	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.
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose	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 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose	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 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.