NCT00337675

Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED)

A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,771 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Not accepted

Summary

This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	montelukast sodium	Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.
DRUG	Comparator: Placebo (unspecified)	Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.
DRUG	montelukast sodium	Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2006-06-16
• Last updated: 2024-05-10
• Results posted: 2010-03-15