Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab(administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).

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

Details

• Lead Sponsor: University of Mississippi Medical Center
• Collaborator: Novartis
• Treatments: Antibodies, Monoclonal; Omalizumab

Criteria

Inclusion Criteria:

• clinical diagnosis and history of moderate persistent allergic asthma

• body weight >/= 20kg and
• Total serum IgE >/= 30 and
• on a stable asthma treatment including corticosteroids for the preceding 4 weeks

• non smoker for at least 1 year prior to visit 1

Exclusion Criteria:

• patients with severe asthma

• history of immunotherapy to any allergen within the past 3 years

• history of anaphylactic allergic reaction

• upper respiratory tract infection