NCT00943397

Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)

A Multicenter, Open-Label, Controlled, Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 6 Months – 2 Years
• Healthy volunteers: Not accepted

Summary

Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol MK0476-176-01, could also enroll.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	montelukast sodium	Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks
DRUG	Comparator: Usual Care	Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks

Timeline

• Start date: 2001-04-01
• Primary completion: 2001-10-01
• Completion: 2001-11-01
• First posted: 2009-07-22
• Last updated: 2022-02-03
• Results posted: 2010-06-17