Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )

Study Overview
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Brief Summary
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A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.

Official Title
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A Multicenter, Double-Blind, Randomized, Parallel-Group Chronic Asthma Study Comparing Montelukast With Placebo in 2- to 5-Year-Old Patients

Conditions
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Asthma

Intervention / Treatment
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* Drug: montelukast sodium
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has history of physician diagnosed asthma Patient is in otherwise good stable health Patient is able to chew a tablet Exclusion Criteria: Patient is hospitalized Patient and/or parent of guardian intends to move or vacation away from home during the course of the study Patient had any major surgical procedure within 4 weeks before the study Patient had active sinus disease within 3 weeks before the study Patient had required intubation for asthma in the past Patient required a visit to the emergency room due to an asthma exacerbation, or has been hospitalized for asthma with in 1 month prior to the study Patient had used inhaled, nebulized, intramuscular, or intravenous steroids with in 1 month before study

Ages Eligible for Study
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Minimum Age: 2 Years
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 |
| --- | --- |
| Experimental: 1<br>Montelukast | Drug: montelukast sodium<br>* one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Comparator: Placebo<br>* one chewable placebo tablet, once daily at bedtime for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Drug-related CAEs Reported by Patients - Base Study | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs | 12 weeks of treatment | 
| Number of Patients With Serious CAEs Reported by Patients - Base Study | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | 12 weeks of treatment | 
| Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study | Patients who reported serious drug-related CAEs during 12 weeks of treatment | 12 weeks of treatment | 
| Number of Patients Who Were Discontinued Due to CAEs - Base Study | Patients who were discontinued due to CAEs during 12 weeks of treatment | 12 weeks of treatment | 
| Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study | Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment | 12 weeks of treatment | 
| Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study | Patients who were discontinued due to serious CAEs during 12 weeks of treatment | 12 weeks of treatment | 
| Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | 12 weeks of treatment | 
| Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs | 12 weeks of treatment | 
| Number of Patients Who Were Discontinued Due to LAEs - Base Study | Patients who were discontinued due to LAEs during 12 weeks of treatment | 12 weeks of treatment | 
| Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study | Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment | 12 weeks of treatment | 
| Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | up to 2.8 years | 
| Number of Patients With Drug-related CAEs Reported by Patients - Extension | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs | up to 2.8 years | 
| Number of Patients With Serious CAEs Reported by Patients - Extension | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | up to 2.8 years | 
| Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension | Patients who reported serious drug-related CAEs up to 2.8 years of treatment | up to 2.8 years | 
| Number of Patients Who Were Discontinued Due to CAEs - Extension | Patients who were discontinued due to CAEs up to 2.8 years of treatment | up to 2.8 years | 
| Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension | Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment | up to 2.8 years | 
| Number of Patients Who Were Discontinued Due to Serious CAEs - Extension | Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment | up to 2.8 years | 
| Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension | Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment | up to 2.8 years | 
| Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | up to 2.8 years | 
| Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs | up to 2.8 years | 
| Number of Patients With Serious LAEs - Extension | Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | up to 2.8 years | 
| Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension | Patients who reported serious drug-related LAEs up to 2.8 years of treatment | up to 2.8 years | 
| Number of Patients Who Were Discontinued Due to LAEs - Extension | Patients who were discontinued due to LAEs up to 2.8 years of treatment | up to 2.8 years | 
| Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension | Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment | up to 2.8 years | 
| Number of Patients Who Were Discontinued Due to Serious LAEs - Extension | Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment | up to 2.8 years | 
| Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension | Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment | up to 2.8 years |