Effect of Omalizumab (Xolair) in Treatment of Patients With AERD and Allergy Asthma
Recruitment status was Recruiting
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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) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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. |
- Respiratory Index scores
- 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 |
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 |
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| 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 | |
| Study Chair: | Gary Willaims, MD, PhD | Vice Chairman of Academic Affairs |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00286416 History of Changes |
| Other Study ID Numbers: | Xolair AERD |
| Study First Received: | February 1, 2006 |
| Last Updated: | November 6, 2006 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Scripps Health:
|
AERD aspirin allergy omalizumab |
Additional relevant MeSH terms:
|
Asthma Rhinitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Nose Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Omalizumab Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 22, 2013