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

Study Overview
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Brief Summary
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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.

Detailed Description
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This study consists of a 4-week placebo run-in period followed by a 24-week double-blind treatment period.

Official Title
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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

Conditions
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Asthma, Bronchial

Intervention / Treatment
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* Drug: Montelukast sodium
* Drug: Placebo to montelukast
* Drug: Fluticasone propionate
* Drug: Placebo to fluticasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montelukast<br>Participants receive montelukast 4 mg oral granules (OG) or 4 mg chewable tablets (CT) once daily (QD) for 24 weeks and placebo to fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks. Participants aged >6 months to <2 years receive montelukast 4 mg packet of OG QD for 24 weeks. Participants aged >2 years to <64 months receive montelukast 4 mg CT QD for 24 weeks. | Drug: Montelukast sodium<br>* Montelukast 4 mg OG or montelukast 4 mg CT<br>* Other names: Singulair®;Drug: Placebo to fluticasone<br>* Placebo inhalation aerosol metered dose inhaler<br>|
| Active Comparator: Fluticasone<br>Participants receive fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks and placebo to montelukast 4 mg QD for 24 weeks. Participants aged >6 months to <2 years receive placebo packet of OG QD for 24 weeks. Participants aged >2 years to <64 months receive placebo CT QD for 24 weeks. | Drug: Placebo to montelukast<br>* Placebo OG or CT<br>Drug: Fluticasone propionate<br>* Fluticasone 50 mcg inhalation aerosol metered dose inhaler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 24 weeks | 
| Number of participants who experience at least one adverse event (AE) |  | Up to 26 weeks | 
| Number of participants who discontinue study drug due to an AE |  | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of days without daytime symptoms |  | 24 weeks | 
| Percentage of days without nighttime cough |  | 24 weeks | 
| Percentage of days without β-agonist use |  | 24 weeks |