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

0476-377

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.

2008-02-01

2010-03-01

2010-03-01

Completed

Early phase I

364

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 364, 'type': 'ACTUAL'}}

2024-05-13