Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Collaborator: Genentech, Inc.
• Treatments: Omalizumab

Criteria

Inclusion Criteria:

• Total Asthma Control Test (ACT) score of ≤19 plus at least one of the following in the 4 weeks preceding visit 1, on average:

• Symptoms > 2 days/week

• Night-time awakenings ≥1 time/week

• Short-acting beta2-agonist (SABA) use for symptom control >2 days/week forced expiratory volume in 1 second (FEV1) ≤ 80% predicted

Exclusion Criteria:

• History of intubation for asthma.

• An asthma exacerbation requiring treatment with systemic steroids within 4 weeks of screening (Visit 1).

• Less than 3 months of stable maintenance oral corticosteroid therapy for asthma

Other protocol-defined inclusion/exclusion criteria applied