NCT00540839

A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)

A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Not accepted

Summary

A study to determine the effects of montelukast (MK-0476) on pediatric participants with chronic asthma compared with fluticasone. The primary hypotheses are that, over 24 weeks of treatment, montelukast will provide at least the same level of asthma control as inhaled fluticasone as measured by the percentage of days without asthma and that, over 24 weeks of treatment, daily administration of montelukast will be safe and well tolerated in children aged 6 months to 5 years with chronic asthma. This trial was stopped at a time before any participants had actually entered the trial. Based on input from regulatory agencies, it is not necessary to conduct this study; a separate ongoing study was sufficient for regulatory purposes.

Detailed description

This study consists of a 4-week placebo run-in period followed by a 24-week double-blind treatment period.

Conditions

• Asthma, Bronchial

Interventions

Type	Name	Description
DRUG	Montelukast sodium	Montelukast 4 mg OG or montelukast 4 mg CT
DRUG	Placebo to montelukast	Placebo OG or CT
DRUG	Fluticasone propionate	Fluticasone 50 mcg inhalation aerosol metered dose inhaler
DRUG	Placebo to fluticasone	Placebo inhalation aerosol metered dose inhaler

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-03-01
• First posted: 2007-10-08
• Last updated: 2022-02-14