NCT00286416

Effect of Omalizumab (Xolair) in Treatment of Patients With AERD and Allergy Asthma

Double Blind Study to Determine Effect of Omalizumab Treatment in Patients With the Co-Morbid Conditions of Aspirin Exacerbated Respiratory Disease(AERD) and Allergic Asthma and Rhinitis.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Scripps Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Double blind protocol treatment of 2/3 of the patients with omalizumab and 1/3 placebo administer for 4 months. Patients selected for the study must have both aspirin exacerbated respiratory disease and allergic asthma and rhinitis. They must also have completed aspirin desensitization and be taking aspirin on a daily basis for the treatment of AERD.

Detailed description

60 patients with Aspirin Exacerbated respiratory Disease will be screened to determine if they also have allergic respiratory tract disease as a co-morbid complication. This will involve history, allergy skin tests and a serum IgE level. They must also have been desensitized to aspirin and be taking aspirin 325 or 650 mg morning and night. 40/60 patients will receive omalizumab injections every month for the next 4 months and the other 20 patients, via a random program, will receive placebo injections. Monthly visits with the nurse co-ordinator will involve the following assessments: daily symptom scores, daily use of medications (particularly prednisone and rescue albuterol inhalers), lung function tests, nasal breathing test, measurement of smell and quality of life scores pre and post study.

Conditions

• Asthma
• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	omalizumab (Xolair)

Timeline

• Start date: 2006-01-01
• Completion: 2008-07-01
• First posted: 2006-02-03
• Last updated: 2006-11-07

Locations

1 site across 1 country: United States