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

Primary Purpose

Asthma, Allergic Rhinitis

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

omalizumab (Xolair)

About this trial

This is an interventional treatment trial for Asthma focused on measuring AERD, aspirin, allergy, omalizumab

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Scripps Clinic at Torrey PinesRecruiting

Outcomes

Primary Outcome Measures

Respiratory Index scores

Secondary Outcome Measures

FEV1

Nasal Flow rates

Nasal smell scores

Quality of Life Scores for rhinitis and asthma

Full Information

NCT ID

NCT00286416

First Posted

February 1, 2006

Last Updated

November 6, 2006

Sponsor

Scripps Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00286416

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2006

Overall Recruitment Status

Unknown status

Study Start Date

January 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Scripps Clinic

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Allergic Rhinitis

Keywords

AERD, aspirin, allergy, omalizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

omalizumab (Xolair)

Primary Outcome Measure Information:

Title

Respiratory Index scores

Secondary Outcome Measure Information:

Title

FEV1

Title

Nasal Flow rates

Title

Nasal smell scores

Title

Quality of Life Scores for rhinitis and asthma

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary Willaims, MD, PhD

Organizational Affiliation

Vice Chairman of Academic Affairs

Official's Role

Study Chair

Facility Information:

Facility Name

Scripps Clinic at Torrey Pines

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christine Decker-Hughes, RN

Phone

858-554-8653

decker-hughes.christine@scrippshealth.org

First Name & Middle Initial & Last Name & Degree

Donald D Stevenson, MD

Phone

858-554-8614

stevenson.donald@scrippshealth.org

First Name & Middle Initial & Last Name & Degree

Donald D Stevenson, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

12668896

Citation

Stevenson DD. Aspirin desensitization in patients with AERD. Clin Rev Allergy Immunol. 2003 Apr;24(2):159-68. doi: 10.1385/CRIAI:24:2:159.

Results Reference

background

PubMed Identifier

12532116

Citation

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. doi: 10.1067/mai.2003.7.

Results Reference

background

Learn more about this trial

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

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