Contribution of Lung Cells in Allergic Asthma

This study has been completed.

First Received: September 16, 2005 Last Updated: February 29, 2008 History of Changes

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00201097

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
Lung Diseases Asthma	Drug: Anti-IgE

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized
Official Title:	Immune Dysregulation in Allergic Asthma

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)

Estimated 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)

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:	UNM HSC ( Mark Schuyler )
Study ID Numbers:	275, P50 HL56384
Study First Received:	September 16, 2005
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00201097 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009