Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)

Organon

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: montelukast sodium; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289874

2006_001

0476-336

Details and patient eligibility

About

This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.

Enrollment: 421 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients, ages 6 to 14 years, with persistent asthma that is also active during allergy season
• Patients must demonstrate positive skin prick tests to seasonally relevant geographic aeroallergens

Exclusion criteria

• Patient cannot have any other acute or chronic pulmonary disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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421 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

montelukast

Treatment:

Drug: montelukast sodium

2

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Comparator: Placebo