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

Organon and Co689 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

689

Conditions

Asthma

Interventions

montelukast sodiumDRUG

one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks

Comparator: PlaceboDRUG

one chewable placebo tablet, once daily at bedtime for 12 weeks

Eligibility

Sex: ALLMin age: 2 YearsMax age: 5 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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