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

Asthma, Exercise-Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245570
• Other study ID #: 0476-316
• Secondary ID: MK0476-3162005_0
• Status: Completed
• Phase: Phase 3
• Start date: December 2005
• Est. completion date: September 2006

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma, Exercise-Induced

Intervention

Drug:
• Comparator: Montelukast
1 dose montelukast 10 mg tablet given orally in one of three treatment periods
• Comparator: Salmeterol
1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods
• Comparator: Placebo (montelukast)
1 dose matching-image placebo to montelukast tablet in two of three treatment periods
• Comparator: Placebo (salmeterol)
1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Philip G, Pearlman DS, Villarán C, Legrand C, Loeys T, Langdon RB, Reiss TF. Single-dose montelukast or salmeterol as protection against exercise-induced bronchoconstriction. Chest. 2007 Sep;132(3):875-83. Epub 2007 Jun 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	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 8.5 Hours Postdose		0-90 minutes after the exercise challenge performed at 8.5 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 8.5 Hours Post-dose 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 (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.	0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose
Secondary	Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose 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.	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	0-60 minutes after the exercise challenge 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 8.5 Hours Postdose	The measure included only the area below the pre-exercise baseline	0-60 minutes after the exercise challenge at 8.5 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 24 Hours Postdose	The measure included only the area below the pre-exercise baseline	0-60 minutes after the exercise challenge 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 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.	Exercise challenge at 8.5 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