First Step With Singulair® Therapy (0476-323)

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction over a 6 week comparison period.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Fluticasone; Montelukast

Criteria

Inclusion Criteria:

• First time diagnosis of mild asthma symptoms which requires an antiinflammatory controller medication

• Patients not controlled with short acting beta2 agonist (sab) therapy (requiring more than one treatment per week but less than 7 per week)

• Patients dissatisfied with low dose ics therapy, or patients reluctant to take ics therapy, or patients insufficiently controlled due to non-compliance with low dose ics therapy through out the preceding 6 weeks

• Patient's forced expiratory volume in one second (fev1) is < 80% of predicted value

Exclusion Criteria:

• Patient on combination therapy

• Patient on long acting beta2 agonists

• Patient on using moderate to high doses of ICS. (ICS >250 µ g/day flovent® or equivalent per day)