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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-07-31

Brief Summary

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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

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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

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Asthma Allergic Rhinitis

Keywords

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AERD aspirin allergy omalizumab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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omalizumab (Xolair)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Gary Willaims, MD, PhD

Role: STUDY_CHAIR

Vice Chairman of Academic Affairs

Locations

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Scripps Clinic at Torrey Pines

La Jolla, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Christine Decker-Hughes, RN

Role: primary

Donald D Stevenson, MD

Role: backup

References

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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.

Reference Type BACKGROUND

PMID: 12668896 (View on PubMed)

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.