Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385)

Phase 4 Completed 445 enrolled Organon and Co

Non-randomizedSingle-groupOpen-labelTreatment

Summary

a study to describe patient and physician satisfaction with montelukast therapy for the control of asthma used either as monotherapy or in combination with inhaled corticosteroids

Timeline

Start: 2006-06
Primary completion: 2008-10
Completion: 2008-10

Outcome

Met primary endpoint

registry analysis (unspecified test); Montelukast ITT at Week 0 vs Montelukast ITT at Week 12; p <0.001; McNemar NCT00832455 ↗

paper By 4 weeks of treatment 61.3% and 52.9% of the patients in the monotherapy and combination group, respectively, achieved asthma control. PMID 24932181 ↗

Publications

Results Berube D, Djandji M, Sampalis JS, Becker A. Effectiveness of montelukast administered as monotherapy or in combination with inhaled corticosteroid in pediatric patients with uncontrolled asthma: a prospective cohort study. Allergy Asthma Clin Immunol. 2014 May 6;10(1):21. doi: 10.1186/1710-1492-10-21. eCollection 2014.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Montelukast	Other / unclassified	4 mg	Oral
Subject	Montelukast	Other / unclassified	5 mg	Oral