Recruiting

Omalizumab

Sponsor:

Scripps Clinic

Code:

NCT00286416

Conditions

Asthma

Allergic Rhinitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

omalizumab (Xolair)

Study Details

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.

Conditions

Asthma

Allergic Rhinitis

Study ID

NCT00286416

Start date

Jan, 2006

Status verified date

Jan, 2006

Completion date

Jul, 2008

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

omalizumab (Xolair)

Primary outcome measure

  • Respiratory Index scores [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Scripps Clinic at Torrey Pines

Recruiting

La Jolla, California, United States, 92037

Contacts

Christine Decker-Hughes, RN

858-554-8653decker-hughes.christine@scrippshealth.org

Donald D Stevenson, MD

858-554-8614stevenson.donald@scrippshealth.org

Principal Investigator:

Donald D Stevenson, MD

More Information

Sponsor

Scripps Clinic

Last update posted

Nov 7, 2006

Last verified

Jan, 2006

Keywords

  • AERD
  • aspirin
  • allergy
  • omalizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Clinic on 2006-11-07.