Clinical trial NCT00286416: Effect of Omalizumab (Xolair) in Treatment of Patients With AERD and Allergy Asthma
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Allergic Rhinitis
Keywords: AERD
aspirin
allergy
omalizumab
Lead sponsor: Scripps Health
Sponsor class: OTHER
First posted: 2006-02-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Respiratory Index scores
Secondary outcomes:
measure: FEV1
measure: Nasal Flow rates
measure: Nasal smell scores
measure: Quality of Life Scores for rhinitis and asthma
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic at Torrey Pines
state: California
Study officials:
affiliation: Vice Chairman of Academic Affairs
name: Gary Willaims, MD, PhD
role: STUDY_CHAIR
References:
citation: Stevenson DD. Aspirin desensitization in patients with AERD. Clin Rev Allergy Immunol. 2003 Apr;24(2):159-68. doi: 10.1385/CRIAI:24:2:159.
citation: 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. doi: 10.1067/mai.2003.7.