Immune Dysfunction in Allergic Asthma

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Drug: Xolair

• Registration Number: NCT00189228
• Lead Sponsor: University of New Mexico

Brief Summary

We are using anti-IgE to investigate the role of pulmonary mast cells in asthma.

Detailed Description

Subjects with mild allergic asthma are examined before, immediately after and 2 months after a course of treatment with anti-IgE. The following are examined: Allergen skin tests, allergen induced asthma, peripheral blood basophils, pulmonary bronchial mucosal mast cells.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-16
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2013-07-23
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-26
• Last Update Submitted: 2019-09-26
• Results First Posted: 2019-09-27
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Mild asthma, adults -

Exclusion Criteria

children. on inhaled or systemic steroids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
xolair	Xolair	This is a single arm, parallel study examining differences of therapeutic outcomes of Xolair. Xolair is being examined as an intervention that might change the outcome of immunization.

Primary Outcome Measures

Name	Time	Method
Anti-KLH Antibody. This is Measured by ELISA and Expressed as ELISA Units Which Are Derived by Dilution of Serum Samples Until the Result Falls on a Linear Portion of the Response Curve. Final Values Are Derived From ELISA Units and the Serum Dilution	6 months	Asthma and control patients are immunized with KLH. Mean levels of anti-KLH antibody as described above. This is measured by ELISA and expressed as ELISA units which are derived by dilution of serum samples until the result falls on a linear portion of the response curve. Final values are derived from ELISA units and the serum dilution

Trial Locations

Locations (1)

UNM HSC; 🇺🇸 Albuquerque, New Mexico, United States