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
  Purpose

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 Intervention
Asthma
Allergic Rhinitis
Drug: omalizumab (Xolair)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Scripps Health:

Primary Outcome Measures:
  • Respiratory Index scores

Secondary Outcome Measures:
  • FEV1
  • Nasal Flow rates
  • Nasal smell scores
  • Quality of Life Scores for rhinitis and asthma

Estimated Enrollment: 60
Study Start Date: January 2006
Estimated Study Completion Date: July 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286416

Locations
United States, California
Scripps Clinic at Torrey Pines Recruiting
La Jolla, California, United States, 92037
Contact: Christine Decker-Hughes, RN    858-554-8653    decker-hughes.christine@scrippshealth.org   
Contact: Donald D Stevenson, MD    858-554-8614    stevenson.donald@scrippshealth.org   
Principal Investigator: Donald D Stevenson, MD         
Sponsors and Collaborators
Scripps Clinic
Investigators
Study Chair: Gary Willaims, MD, PhD Vice Chairman of Academic Affairs
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00286416     History of Changes
Other Study ID Numbers: Xolair AERD
Study First Received: February 1, 2006
Last Updated: November 6, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Scripps Health:
AERD
aspirin
allergy
omalizumab

Additional relevant MeSH terms:
Asthma
Rhinitis
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014