Clinical trial NCT00245570: Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma, Exercise-Induced
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-10-28
Enrollment: 47
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose
Secondary outcomes:
measure: Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose
timeFrame: 0-90 minutes after the exercise challenge performed at 2 hours postdose
measure: Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose
timeFrame: 0-90 minutes after the exercise challenge performed at 8.5 hours postdose
measure: Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose
timeFrame: 0-90 minutes after the exercise challenge performed at 24 hours postdose
measure: Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB
timeFrame: 0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose
measure: Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB
timeFrame: 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose
measure: 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
timeFrame: 0-60 minutes after the exercise challenge at 2 hours postdose
measure: 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
timeFrame: 0-60 minutes after the exercise challenge at 8.5 hours postdose
measure: 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
timeFrame: 0-60 minutes after the exercise challenge at 24 hours postdose
measure: Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose
timeFrame: Exercise challenge at 2 hours postdose
measure: Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose
timeFrame: Exercise challenge at 8.5 hours postdose
measure: Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose
timeFrame: Exercise challenge at 24 hours postdose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Philip G, Pearlman DS, Villaran 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. doi: 10.1378/chest.07-0550. Epub 2007 Jun 15.