Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED)

Study Overview
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Brief Summary
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This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).

Official Title
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A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years

Conditions
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Asthma

Intervention / Treatment
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* Drug: montelukast sodium
* Drug: Comparator: Placebo (unspecified)
* Drug: montelukast sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 6 months to 5 years with episodic (periodic) asthma Exclusion Criteria: Patients who are not in otherwise good health Patients who have persistent asthma (continual asthma symptoms)

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: drug + episodic supplemental placebo<br>Montelukast once a day (qd) + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period | Drug: montelukast sodium<br>* Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.<br>* Other names: Singulair®;|
| Active Comparator: Arm 2: placebo comparator + episodic supplemental drug<br>Placebo qd + episode driven supplemental Montelukast qd for 12 days for a 52-wk treatment period | Drug: montelukast sodium<br>* Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.<br>* Other names: Singulair®;|
| Placebo Comparator: Arm 3: placebo comparator + episodic supplemental placebo<br>Placebo qd + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period | Drug: Comparator: Placebo (unspecified)<br>* Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period | The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient's legal guardian recorded all the HRU that was required specifically for breathing problems. | 1-year treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode | Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of wheeze and difficulty breathing on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 3 days prior to an asthma attack was reported. If a patient had multiple episodes during 1 year, the symptom scores were averaged across all the episodes. | 1 Year | 
| Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes | Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of Wheeze, Difficulty Breathing, Interference with Activity, and Daytime Cough on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 12 days of intermittent treatment for an episode (before the first attack) was reported. If a patient had multiple episodes over 1 year, the symptom scores were averaged across all the episodes. | 1 Year |