Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286416
Status:
UNKNOWN
Last Update Posted:
2006-11-07
First Post:
2006-02-01
Brief Title:
Effect of Omalizumab Xolair in Treatment of Patients With AERD and Allergy Asthma
Sponsor:
Scripps Clinic
Organization:
Scripps Health
Study Overview
Official Title:
Double Blind Study to Determine Effect of Omalizumab Treatment in Patients With the Co-Morbid Conditions of Aspirin Exacerbated Respiratory DiseaseAERD and Allergic Asthma and Rhinitis
Status:
UNKNOWN
Status Verified Date:
2006-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Double blind protocol treatment of 23 of the patients with omalizumab and 13 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
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
4060 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
4060 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None