Back to resultsImmune Dysfunction in Allergic Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Xolair
Sponsored by
About this trial
This is an interventional basic science trial for Asthma
Eligibility Criteria
Inclusion Criteria: Mild asthma, adults - Exclusion Criteria: children. on inhaled or systemic steroids -
Sites / Locations
- UNM HSC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
xolair
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00189228
First Posted
September 10, 2005
Last Updated
September 26, 2019
Sponsor
University of New Mexico
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00189228
Brief Title
Immune Dysfunction in Allergic Asthma
Official Title
Not a Drug Trial. We Are Using Anti-IgE to Examine the Role of Pulmonary Mast Cells in Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
xolair
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Xolair
Intervention Description
Patients are administered Xolair
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild asthma, adults -
Exclusion Criteria:
children. on inhaled or systemic steroids
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Schuyler, MD
Organizational Affiliation
UNM HSC
Official's Role
Study Director
Facility Information:
Facility Name
UNM HSC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Immune Dysfunction in Allergic Asthma
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