Clinical trial NCT00534976: The Effect of Montelukast on Difficulty in Breathing After Exercise in Pediatric Patients (MK0476-377)(COMPLETED)
Official title: A Double-Blind, Placebo-Controlled, Multicenter, Crossover Study to Evaluate the Effects of a Single Oral Dose of Montelukast, Compared With Placebo, on Exercise-Induced Bronchoconstriction (EIB) in Pediatric Patients Aged 4 to 14 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Exercise-induced Bronchoconstriction (EIB)
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 364
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will see if there is a change in breathing after exercising when the child receives study drug ( montelukast or placebo). Breathing will be measured by a spirometer before exercising and measured again several times after exercising.


Eligibility criteria: Inclusion Criteria:

* The child is 4 years to 14 years of age
* The child is a non smoker
* The child has exercise-induced bronchoconstriction (EIB)

Exclusion Criteria:

* The child has active or chronic breathing disease, other than asthma
* The child has required insertion of a breathing tube for asthma
* The child had major surgery within the last 4 weeks
* The child is currently in the hospital
* The child has or had an upper respiratory tract infection within the last 2 weeks
* The child has been hospitalized or visited the emergency room or had a change in their medication for asthma within the last 4 weeks
* The child has been in a research study in the last 4 weeks
* The child has stomach, brain, heart, kidney or liver disease
* The child drinks more that 4 caffeinated drinks a day

Primary outcomes:
measure: Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose
timeFrame: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose
Secondary outcomes:
measure: Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose
timeFrame: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 24 hours post-dose
measure: Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 2 Hours Post-dose
timeFrame: Pre-exercise baseline to 60 minutes after the exercise challenge performed 2 hours post-dose
measure: Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 24 Hours Post-dose
timeFrame: Pre-exercise baseline to 60 minutes after the exercise challenge performed 24 hours post-dose
measure: Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose
timeFrame: 0-60 minutes and 0-90 minutes after the exercise challenge at 2 hours postdose
measure: Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose
timeFrame: 0-60 minutes and 0-90 minutes after the exercise challenge at 24 hours postdose
measure: Number of Participants Requiring Rescue Medication at 2 Hours Postdose
timeFrame: 0-90 minutes after the exercise challenge at 2 hours postdose
measure: Number of Participants Requiring Rescue Medication at 24 Hours Postdose
timeFrame: 0-90 minutes after the exercise challenge at 24 hours postdose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Wasfi YS, Kemp JP, Villaran C, Massaad R, Xin W, Smugar SS, Knorr BA, Philip G. Onset and duration of attenuation of exercise-induced bronchoconstriction in children by single-dose of montelukast. Allergy Asthma Proc. 2011 Nov-Dec;32(6):453-9. doi: 10.2500/aap.2011.32.3482.