A Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics (0476-329)

Organon

Status and phase: Completed; Phase 4

Conditions: Asthma; Allergic Rhinitis

Treatments: Drug: Comparator: theophylline ER/Duration of Treatment: 16 weeks; Drug: MK0476; montelukast sodium/Duration of Treatment: 16 weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00157937

0476-329

2005_069

Details and patient eligibility

About

Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week wash-out period and 8-week comparator drug or the drug administration period (with cross-over design) for assessment of the drug efficacy, safety and tolerability.

Enrollment: 31 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Males or females between the ages of 18 and 60 with mild to moderate asthma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)