A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165)

Organon

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Comparator: placebo; Drug: MK0476; montelukast sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00140881

0476-165

2005_055

Details and patient eligibility

About

A 53-week study to determine the effect of montelukast sodium when given to children (with infrequent episodic asthma) at the earliest symptoms of an acute episode of asthma.

Enrollment: 220 patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Males or females between the ages of 2 and 14 who have infrequent episodic asthma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind