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Effect of Omalizumab (Xolair) in Treatment of Patients With AERD and Allergy Asthma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Scripps Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Scripps Health
ClinicalTrials.gov Identifier:
NCT00286416
First received: February 1, 2006
Last updated: November 6, 2006
Last verified: January 2006

February 1, 2006
November 6, 2006
January 2006
Not Provided
Respiratory Index scores
Same as current
Complete list of historical versions of study NCT00286416 on ClinicalTrials.gov Archive Site
  • FEV1
  • Nasal Flow rates
  • Nasal smell scores
  • Quality of Life Scores for rhinitis and asthma
Same as current
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Asthma
  • Allergic Rhinitis
Drug: omalizumab (Xolair)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2008
Not Provided

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.
Both
18 Years to 90 Years
No
United States
 
NCT00286416
Xolair AERD
Not Provided
Not Provided
Scripps Clinic
Not Provided
Study Chair: Gary Willaims, MD, PhD Vice Chairman of Academic Affairs
Scripps Health
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP