A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)

A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma

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.

Inclusion Criteria:

• Between 6 months and 5 years, 4 months of age
• Diagnosed with asthma by a doctor
• At least 3 episodes of asthma symptoms within the last 6 months

Exclusion Criteria:

• Active or chronic breathing disease, other than asthma
• Required insertion of a breathing tube for asthma
• Major surgery within the last 4 weeks
• Currently in the hospital
• Allergic to certain drugs, and for children under 2 years of age, apples, applesauce and formula