Clinical trial NCT00090142: Montelukast in Exercise-Induced Bronchospasm - 2004 (0476-275)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma, Exercise-Induced
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-08-26
Enrollment: 62
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose
Secondary outcomes:
measure: Number of Patients Requiring ß-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 ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose
timeFrame: 0-90 minutes after the exercise challenge performed at 12 hours postdose
measure: Number of Patients Requiring ß-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 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB
timeFrame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose
measure: Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB
timeFrame: Pre-exercise baseline measurement and 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: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 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 12 Hours Postdose
timeFrame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose
measure: 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
timeFrame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 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 12 Hours Postdose
timeFrame: Exercise challenge at 12 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, Villaran 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. doi: 10.1080/02770900701209806.