Effect of Omalizumab (Xolair) in Treatment of Patients With AERD and Allergy Asthma
Information source: Scripps Health
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma; Allergic Rhinitis
Intervention: omalizumab (Xolair) (Drug)
Sponsored by: Scripps Clinic
Official(s) and/or principal investigator(s):
Gary Willaims, MD, PhD, Study Chair, Affiliation: Vice Chairman of Academic Affairs
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.
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Respiratory Index scores
Nasal Flow rates
Nasal smell scores
Quality of Life Scores for rhinitis and asthma
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.
Minimum age: 18 Years.
Maximum age: 90 Years.
aspirin exacerbated respiratory disease and allergic asthma
- 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.
Locations and Contacts
Scripps Clinic at Torrey Pines, La Jolla, California 92037, United States; Recruiting
Christine Decker-Hughes, RN, Phone: 858-554-8653, Email: firstname.lastname@example.org
Donald D Stevenson, MD, Phone: 858-554-8614, Email: email@example.com
Donald D Stevenson, MD, Principal Investigator
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.
Starting date: January 2006
Last updated: November 6, 2006