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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: montelukast sodium

• Registration Number: NCT00289874
• Lead Sponsor: Organon and Co

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-08
• Study First Posted: 2006-02-10
• Study Start: 2006-03
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Results First Submitted: 2009-09-09
• Results First Submitted QC: 2010-09-10
• Results First Posted: 2010-10-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 421

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	montelukast sodium	montelukast

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3	Baseline and week 3	Percent change from baseline in FEV1, a measure of airway function, at Week 3

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period	Baseline and Week 3	Percent change from baseline in average daily β-agonist use over the 3-week treatment period