First Step With Singulair® Therapy (0476-323) (FIRST)

Organon

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Comparator: Fluticasone / Duration of Treatment: 6 Weeks; Drug: MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545324

2007_025

0476-323

Details and patient eligibility

About

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.

Enrollment: 399 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 &micro g/day flovent&reg; or equivalent per day)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)