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.
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable asthma
Started Jan 2006
Typical duration for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 1, 2006
CompletedFirst Posted
Study publicly available on registry
February 3, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedNovember 7, 2006
January 1, 2006
February 1, 2006
November 6, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Respiratory Index scores
Secondary Outcomes (4)
FEV1
Nasal Flow rates
Nasal smell scores
Quality of Life Scores for rhinitis and asthma
Interventions
Eligibility Criteria
You may qualify if:
- aspirin exacerbated respiratory disease and allergic asthma
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scripps Cliniclead
Study Sites (1)
Scripps Clinic at Torrey Pines
La Jolla, California, 92037, United States
Related Publications (2)
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.
PMID: 12668896BACKGROUNDBerges-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.
PMID: 12532116BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gary Willaims, MD, PhD
Vice Chairman of Academic Affairs
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 1, 2006
First Posted
February 3, 2006
Study Start
January 1, 2006
Study Completion
July 1, 2008
Last Updated
November 7, 2006
Record last verified: 2006-01