A study to determine the effects of montelukast (MK-0476) on pediatric participants with chronic asthma compared with fluticasone. The primary hypotheses are that, over 24 weeks of treatment, montelukast will provide at least the same level of asthma control as inhaled fluticasone as measured by the percentage of days without asthma and that, over 24 weeks of treatment, daily administration of montelukast will be safe and well tolerated in children aged 6 months to 5 years with chronic asthma. This trial was stopped at a time before any participants had actually entered the trial. Based on input from regulatory agencies, it is not necessary to conduct this study; a separate ongoing study was sufficient for regulatory purposes.
This study consists of a 4-week placebo run-in period followed by a 24-week double-blind treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Montelukast 4 mg OG or montelukast 4 mg CT
Placebo OG or CT
Fluticasone 50 mcg inhalation aerosol metered dose inhaler
Percentage of days without asthma
A day without asthma is defined as a day with all of the following: no daytime symptoms, no nighttime cough, no β-agonist use, and no asthma attack (defined as a visit to a doctor, urgent care clinic, emergency room, or hospital for asthma \[other than a scheduled visit to a doctor\], or treatment with systemic corticosteroid during the previous 24 hours).
Time frame: 24 weeks
Number of participants who experience at least one adverse event (AE)
Time frame: Up to 26 weeks
Number of participants who discontinue study drug due to an AE
Time frame: Up to 24 weeks
Percentage of days without daytime symptoms
Time frame: 24 weeks
Percentage of days without nighttime cough
Time frame: 24 weeks
Percentage of days without β-agonist use
Time frame: 24 weeks
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Placebo inhalation aerosol metered dose inhaler