A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165)

Organon and Co220 enrolled

Overview

A 53-week study to determine the effect of montelukast sodium when given to children (with infrequent episodic asthma) at the earliest symptoms of an acute episode of asthma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

220

Conditions

Asthma

Interventions

MK0476; montelukast sodiumDRUG

Comparator: placeboDRUG

Eligibility

Sex: ALLMin age: 2 YearsMax age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females between the ages of 2 and 14 who have infrequent episodic asthma.

Outcomes

Primary Outcomes

Composite unscheduled acute health care resource utilisation (specific for asthma; unscheduled visits, GP attendance, ED attendance and hospital admission).

Secondary Outcomes

Parent/caregiver QOL endpoints.

The safety and tolerability of montelukast when use as an episode modifier.

The duration and severity of the episode assessed by the parent/caregiver symptom score and the use of b-agonist and oral corticosteroid.

Data from ClinicalTrials.gov

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