NCT00226200

Soluble CD23 Expression in Asthma Patients Treated With OMA

Soluble CD23 Expression as a Marker of Immunomodulation and CLinical Response in Asthma Patients Treated With Omalizumab

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (planned)
• Sponsor: University of Mississippi Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study involves a FDA approved drug, Omalizumab, used in the treatment of moderate to severe allergic asthma that cannot be controlled by standard treatment. It works on IgE to control the allergic reaction. We are looking at the effects on non-allergic asthma. We hope to prove that Omalizumab will have the same effect on non-allergic asthmatics as it does allergic asthmatics.

Detailed description

This is a 1 year placebo controlled study looking at moderate to severe asthmatics (allergic or non-allergic) who are controlled by medication. Skin testing will be done to determine the allergic status, as well as a base line IgE done. The Omalizumab is administered by injection based on weight and IgE level, (once or twice a month). At several times during the year pulmonary function test will be done, as well blood drawn for immunological assays (CD23 and FcER1 expression, TH1/TH2 cytokines, CD23 production). A battery of questionnaires will also determine quality of life(with asthma), psychological stress measures and parameters of clinical response.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Omalizumab

Timeline

• Start date: 2004-11-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2005-09-26
• Last updated: 2008-12-01

Locations

1 site across 1 country: United States