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Contribution of Lung Cells in Allergic Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Schuyler, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00201097
First received: September 16, 2005
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to examine bronchial mucosal mast cells before, immediately after, and 2 months after a course of treatment with anti-immunoglobulin (Ig)E.


Condition Intervention Phase
Lung Diseases
Asthma
 Drug: Anti-IgE
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Immune Dysregulation in Allergic Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab
U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Bronchial mucosal mast cells (measured at Months 0 and 2) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Asthmatics are administered Omalizumab and immunized with KLH


Enrollment: 18
Study Start Date: December 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Anti-IgE
    The usual clinical dose
    Other Name: Omalizumab
Detailed Description:

BACKGROUND:

Pulmonary mast cells are thought to be important in both acute asthma episodes and the pathogenesis of asthma. The study will use the recently released anti-IgE, which has been demonstrated to dramatically decrease IgE receptor expression on circulating basophils, as a probe to assess the contribution of pulmonary mast cells to asthma.

DESIGN NARRATIVE:

Well-characterized mild atopic asthmatics will be treated with anti-IgE. Allergen induced asthma, allergen skin tests, basophil IgE receptors, and pulmonary mucosal mast cells well be examined before, immediately after, and 2 months after treatment with anti-IgE.

  Eligibility

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

Inclusion Criteria:

  • History of asthma
  • Either a greater than or equal to 15% increase of FEV1 in response to 200ug albuterol or increased sensitivity to inhaled methacholine
  • Agree to use effective birth control methods, if female

Exclusion Criteria:

  • Use of glucocorticosteroid medication (either inhaled or systemic) within 6 months prior to study entry
  • Chronic illness other than asthma
  • Current smoking
  • Administration of allergen immunotherapy within 6 months prior to study entry
  • Abnormal physical examination focusing on the lung
  • History of alcohol or drug abuse
  • Negative allergy skin tests
  • Serum IgE greater than 700 IU/ml
  • History of HIV risk factors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00201097

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

No publications provided

Responsible Party: Mark Schuyler, Professor of Medicine, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00201097     History of Changes
Other Study ID Numbers: 275, P50 HL56384
Study First Received: September 16, 2005
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013