Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)

Organon and Co190 enrolled

Overview

Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol MK0476-176-01, could also enroll.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

190

Conditions

Asthma

Interventions

montelukast sodiumDRUG

Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks

Comparator: Usual CareDRUG

Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient successfully completed visit 5 of MK0476 Protocol 176 (NCT00943683) OR: * Patient is in good, stable health * Patient has been fed solid foods for at least 1 month * Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit * Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines Exclusion Criteria: * Patient was hospitalized at the start of the study or had any major surgery 4 weeks prior * Patient had an allergy to apples or applesauce

Outcomes

Primary Outcomes

Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment

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

Time frame: Up to 52 weeks of treatment

Data from ClinicalTrials.gov

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