Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)

Organon and Co421 enrolled

Overview

This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

421

Conditions

Asthma

Interventions

montelukast sodiumDRUG

montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.

Comparator: PlaceboDRUG

Placebo. Up to 3 weeks of treatment

Eligibility

Sex: ALLMin age: 6 YearsMax age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female patients, ages 6 to 14 years, with persistent asthma that is also active during allergy season * Patients must demonstrate positive skin prick tests to seasonally relevant geographic aeroallergens Exclusion Criteria: * Patient cannot have any other acute or chronic pulmonary disorder

Outcomes

Primary Outcomes

Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3

Percent change from baseline in FEV1, a measure of airway function, at Week 3

Time frame: Baseline and week 3

Secondary Outcomes

Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period

Percent change from baseline in average daily β-agonist use over the 3-week treatment period

Time frame: Baseline and Week 3

Data from ClinicalTrials.gov

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