Use of Montelukast to Treat Children With Mild to Moderate Acute Asthma

Summary

The primary objective of this study is to evaluate if children with acute asthma given a single dose of oral prednisolone with a subsequent daily five-day course of oral Montelukast will achieve a therapeutic failure rate at day 8 not significantly higher than those given six daily doses of oral prednisolone. Secondary objectives include comparison of the two groups with respect to the changes in symptoms, beta2 agonists, clinical asthma score and days without asthma by day 8.

Timeline

Start

2005-09

Primary completion

2008-02

Completion

2008-02

Outcome

Missed primary endpoint

paper The rates of treatment failure were 7.9% in the prednisolone group and 22.4% in the montelukast group (95% CI, 26.5%-2.4%). PMID 19656525 ↗

paper Montelukast does not represent an adequate alternative to corticosteroids after outpatient stabilization in mild to moderate acute asthma. PMID 19656525 ↗

Publications

• Results Schuh S, Willan AR, Stephens D, Dick PT, Coates A. Can montelukast shorten prednisolone therapy in children with mild to moderate acute asthma? A randomized controlled trial. J Pediatr. 2009 Dec;155(6):795-800. doi: 10.1016/j.jpeds.2009.06.008. Epub 2009 Aug 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Montelukast	Other / unclassified	4 mg	Oral
Subject	Montelukast	Other / unclassified	5 mg	Oral
Subject	Montelukast	Other / unclassified	10 mg	Oral
Comparator	Prednisolone	Other / unclassified	1 mg/kg	Oral
Comparator	Prednisolone	Other / unclassified	2 mg/kg	Oral

Indications