Montelukast Back to School Asthma Study (0476-340)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-11-30

Brief Summary

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This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

montelukast

Group Type EXPERIMENTAL

montelukast

Intervention Type DRUG

montelukast 5 mg tablet Once a day (QD) for 8 weeks

2

Placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

Placebo to montelukast QD for 8 weeks

Interventions

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montelukast

montelukast 5 mg tablet Once a day (QD) for 8 weeks

Intervention Type DRUG

Comparator: Placebo

Placebo to montelukast QD for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female non-smoking Participants, ages 6 to 14 years, with chronic asthma, history of at least one asthma exacerbation associated with a cold within the past year and a documented history of asthma that required treatment with any asthma medication within 6 months prior to Visit 1

Exclusion Criteria

* Participant cannot have any other acute or chronic pulmonary disorder, or hospitalization for asthma more than three times within one year prior to signing informed consent

Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No