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Immune Dysfunction in Allergic Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00189228
First Posted: September 16, 2005
Last Update Posted: January 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Mark Schuyler, University of New Mexico
  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: None (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 Mark Schuyler, University of New Mexico:

Primary Outcome Measures:
  • anti-KLH antibody [ Time Frame: 6 months ]
    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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Mild asthma, adults -

Exclusion Criteria:

children. on inhaled or systemic steroids

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189228


Locations
United States, New Mexico
UNM HSC
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Director: Mark Schuyler, MD UNM HSC
  More Information

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 ( U.S. NIH Grant/Contract )
First Submitted: September 10, 2005
First Posted: September 16, 2005
Last Update Posted: January 23, 2013
Last Verified: January 2013

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
Anti-Asthmatic Agents
Respiratory System Agents