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

Phase 4

Completed

• Conditions: Asthma

• Registration Number: NCT00140881
• Lead Sponsor: Organon and Co

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-06-01
• Primary Completion: 2003-02-14
• Study Completion: 2003-02-14
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Males or females between the ages of 2 and 14 who have infrequent episodic asthma.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.