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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00286416
Recruitment Status : Unknown
Verified January 2006 by Scripps Health.
Recruitment status was:  Recruiting
First Posted : February 3, 2006
Last Update Posted : November 7, 2006
Information provided by:
Scripps Health

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.

Condition or disease Intervention/treatment Phase
Asthma Allergic Rhinitis Drug: omalizumab (Xolair) Not Applicable

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.

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : January 2006
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab

Primary Outcome Measures :
  1. Respiratory Index scores

Secondary Outcome Measures :
  1. FEV1
  2. Nasal Flow rates
  3. Nasal smell scores
  4. Quality of Life Scores for rhinitis and asthma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00286416

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United States, California
Scripps Clinic at Torrey Pines Recruiting
La Jolla, California, United States, 92037
Contact: Christine Decker-Hughes, RN    858-554-8653   
Contact: Donald D Stevenson, MD    858-554-8614   
Principal Investigator: Donald D Stevenson, MD         
Sponsors and Collaborators
Scripps Clinic
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Study Chair: Gary Willaims, MD, PhD Vice Chairman of Academic Affairs
Layout table for additonal information Identifier: NCT00286416    
Other Study ID Numbers: Xolair AERD
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: November 7, 2006
Last Verified: January 2006
Keywords provided by Scripps Health:
Additional relevant MeSH terms:
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Rhinitis, Allergic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents