- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- Recruiting
- Scripps Clinic at Torrey Pines
-
Contact:
- Christine Decker-Hughes, RN
- Phone Number: 858-554-8653
- Email: decker-hughes.christine@scrippshealth.org
-
Contact:
- Donald D Stevenson, MD
- Phone Number: 858-554-8614
- Email: stevenson.donald@scrippshealth.org
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Principal Investigator:
- Donald D Stevenson, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Respiratory Index scores
|
Secondary Outcome Measures
Outcome Measure |
---|
FEV1
|
Nasal Flow rates
|
Nasal smell scores
|
Quality of Life Scores for rhinitis and asthma
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gary Willaims, MD, PhD, Vice Chairman of Academic Affairs
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Otorhinolaryngologic Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Asthma
- Rhinitis
- Rhinitis, Allergic
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Omalizumab
Other Study ID Numbers
- Xolair AERD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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