Effect of Omalizumab (Xolair) in Treatment of Patients With AERD and Allergy Asthma - Full Text View

Sponsored by:	Scripps Clinic
Information provided by:	Scripps Health
ClinicalTrials.gov Identifier:	NCT00286416

Purpose

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.

Condition	Intervention
Asthma Allergic Rhinitis	Drug: omalizumab (Xolair)

MedlinePlus related topics: Allergy Asthma

Drug Information available for: Omalizumab Acetylsalicylic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by Scripps Health:

Primary Outcome Measures:

Respiratory Index scores

Secondary Outcome Measures:

FEV1
Nasal Flow rates
Nasal smell scores
Quality of Life Scores for rhinitis and asthma

Estimated Enrollment:	60
Study Start Date:	January 2006
Estimated Study Completion Date:	July 2008

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

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286416

Locations

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

Sponsors and Collaborators

Scripps Clinic

Investigators

Study Chair:

Gary Willaims, MD, PhD

Vice Chairman of Academic Affairs

More Information

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.

Study ID Numbers:	Xolair AERD
Study First Received:	February 1, 2006
Last Updated:	November 6, 2006
ClinicalTrials.gov Identifier:	NCT00286416
Health Authority:	United States: Institutional Review Board

Keywords provided by Scripps Health:

AERD
aspirin
allergy
omalizumab

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiration Disorders
Asthma
Rhinitis
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases

Respiratory Tract Infections
Aspirin
Lung Diseases
Hypersensitivity, Immediate
Respiratory Hypersensitivity
Omalizumab

Additional relevant MeSH terms:

Respiratory System Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses

Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009