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

Asthma, Exercise-Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090142
• Other study ID #: 0476-275
• Secondary ID: 2004_009
• Status: Completed
• Phase: Phase 3
• Start date: May 2004
• Est. completion date: October 2004

Study information

• Verified date: January 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma, Exercise-Induced
• Bronchial Spasm

Intervention

Drug:
• Comparator: Montelukast
Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge
• Comparator: Placebo
Placebo tablet administered orally as a single witnessed dose before exercise challenge

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Philip G, Villarán C, Pearlman DS, Loeys T, Dass SB, Reiss TF. Protection against exercise-induced bronchoconstriction two hours after a single oral dose of montelukast. J Asthma. 2007 Apr;44(3):213-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose
Secondary	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
Secondary	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
Secondary	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
Secondary	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.	Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose
Secondary	Maximum Percent Fall in FEV1 After Exercise Challenge at 24 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 (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.	Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose
Secondary	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.	Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose
Secondary	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.	Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose
Secondary	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.	Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose
Secondary	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.	Exercise challenge at 2 hours postdose
Secondary	Time to Recovery From Maximum Percentage Decrease in FEV1 After 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 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.	Exercise challenge at 12 hours postdose
Secondary	Time to Recovery From Maximum Percentage Decrease in FEV1 After 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.	Exercise challenge at 24 hours postdose