Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316)

Phase 3

Completed

• Conditions: Asthma, Exercise-Induced

• Registration Number: NCT00245570
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-10-26
• Study First Submitted QC: 2005-10-27
• Study First Posted: 2005-10-28
• Study Start: 2005-12
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Results First Submitted: 2009-09-25
• Results First Submitted QC: 2010-04-29
• Results First Posted: 2010-05-27
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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)	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 Outcome Measures

Name	Time	Method
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	In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (8.5 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 Post-dose in Patients With EIB	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 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.
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	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 0-60 Min) at 8.5 Hours Postdose	0-60 minutes after the exercise challenge at 8.5 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 0-60 Min) at 24 Hours Postdose	0-60 minutes after the exercise challenge 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 after exercise challenge 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 8.5 Hours Postdose	Exercise challenge at 8.5 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 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 after exercise challenge occurs and the; time when FEV1 returns to within 5% of the preexercise baseline for the first time.