Immune Dysfunction in Allergic Asthma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mark Schuyler, University of New Mexico
ClinicalTrials.gov Identifier:
NCT00189228
First received: September 10, 2005
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention
Asthma
Drug: Xolair

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Not a Drug Trial. We Are Using Anti-IgE to Examine the Role of Pulmonary Mast Cells in Asthma

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • anti-KLH antibody [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Asthma and control patients are immunized with KLH


Enrollment: 18
Study Start Date: September 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: xolair
This is not a drug study examining differences of therapeutic outcomes. It uses Xolair as an intervention that might change the outcome of immunization.
Drug: Xolair
Patients are administered Xolair
Other Name: Xolair

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Mild asthma, adults -

Exclusion Criteria:

children. on inhaled or systemic steroids

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189228

Locations
United States, New Mexico
UNM HSC
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Study Director: Mark Schuyler, MD UNM HSC
  More Information

No publications provided

Responsible Party: Mark Schuyler, Professor of Medicine, University of New Mexico
ClinicalTrials.gov Identifier: NCT00189228     History of Changes
Obsolete Identifiers: NCT00201097
Other Study ID Numbers: UNMSCOR, R01HL044253
Study First Received: September 10, 2005
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 17, 2014