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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00286416
• Other study ID #: Xolair AERD
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2006
• Last updated: November 6, 2006
• Start date: January 2006
• Est. completion date: July 2008

Study information

• Verified date: January 2006
• Source: Scripps Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Rhinitis

Intervention

Drug:
• omalizumab (Xolair)

Locations

Country	Name	City	State
United States	Scripps Clinic at Torrey Pines	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Clinic

Country where clinical trial is conducted

United States, 

References & Publications (2)

Berges-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. — View Citation

Stevenson DD. Aspirin desensitization in patients with AERD. Clin Rev Allergy Immunol. 2003 Apr;24(2):159-68. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Index scores
Secondary	FEV1
Secondary	Nasal Flow rates
Secondary	Nasal smell scores
Secondary	Quality of Life Scores for rhinitis and asthma