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

Condition(s) targeted: Asthma; Allergic Rhinitis

Intervention: omalizumab (Xolair) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Scripps Clinic

Official(s) and/or principal investigator(s):
Gary Willaims, MD, PhD, Study Chair, Affiliation: Vice Chairman of Academic Affairs

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.

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Respiratory Index scores

Secondary outcome:

FEV1

Nasal Flow rates

Nasal smell scores

Quality of Life Scores for rhinitis and asthma

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.

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

aspirin exacerbated respiratory disease and allergic asthma

Exclusion Criteria:

- pregnant females,starting immunotherapy in the past 3 months, prior treatment with

Xolair, negative allergy skin tests,unable to participate in lung function tests, unable to complete data forms,low platelets, serum IGE greater than 700 iu,cancer,another uncontrolled medical condition, unacceptable concomitant medication, under the age of 18 years.

Scripps Clinic at Torrey Pines, La Jolla, California 92037, United States; Recruiting
Christine Decker-Hughes, RN, Phone: 858-554-8653, Email: decker-hughes.christine@scrippshealth.org
Donald D Stevenson, MD, Phone: 858-554-8614, Email: stevenson.donald@scrippshealth.org
Donald D Stevenson, MD, Principal Investigator

Related publications:

Stevenson DD. Aspirin desensitization in patients with AERD. Clin Rev Allergy Immunol. 2003 Apr;24(2):159-68. Review.

Berges-Gimeno MP, Simon RA, Stevenson DD. Long-term treatment with aspirin desensitization in asthmatic patients with aspirin-exacerbated respiratory disease. J Allergy Clin Immunol. 2003 Jan;111(1):180-6.

Starting date: January 2006
Last updated: November 6, 2006