NCT00245570

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 15 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma, Exercise-Induced

Interventions

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

Timeline

• Start date: 2005-12-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2005-10-28
• Last updated: 2022-02-02
• Results posted: 2010-05-27