Desensitization of Human Mast Cells: Mechanisms and Potential Utility for Preventing Anaphylaxis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00868842
First received: March 23, 2009
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

This is an open-label, single-center study of whether oral penicillin desensitization of healthy sensitive subjects results in allergen cross-desensitization of mast cells by skin testing and desensitization of peripheral blood basophils. The primary endpoint(s) will be PC3 prick skin test values to penicillin, aeroallergen(s) and codeine. Secondary endpoints will be levels of Syk in purified basophils determined by flow cytometry (mean fluorescence intensity) and basophil degranulation (% tryptase release) to anti-FcåRI and to calcium ionophore.


Condition
Anaphylaxis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Open-label, Single-center Study of Whether Oral Penicillin Desensitization of Healthy Sensitive Subjects Results in Allergen Cross-desensitization of Mast Cells by Skin Testing and Desensitization of Peripheral Blood Basophils.

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Decreased skin test sensitivity to Pre-pen (PC3 value) [ Time Frame: June 2012 ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: January 2009
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Clinical and community recruitment

Criteria

Inclusion Criteria:

  • Written informed consent obtained.
  • Male, or non-pregnant female, 18-45 years of age who are in good health.
  • Clinical history of a penicillin allergy consisting of an immediate hyper- sensitivity reaction such as anaphylaxis, urticaria/angioedema or broncho- spasm, and a positive skin prick test to penicillin G.
  • Positive skin test to at least one aeroallergen to indicate sensitivity, but clinical disease (allergic rhinitis) is not necessary.

Exclusion Criteria:

  • Dermatographism or severe dermatologic condition, such as advanced eczema or psoriasis, that will not allow an adequate uninvolved area for skin testing.
  • Negative skin tests to penicillin G or to all aeroallergens test.
  • Pregnancy.
  • Antihistamine medications taken within one week of testing; systemic steroids, B-blockers or ACE -inhibitors taken over the previous month; omalizumab therapy at any time; those receiving or who have received immunotherapy; and those who have been desensitized to any drug within 6 months.
  • Allergic reaction to a B-lactam antibiotic within 1 month.
  • Current asthma; significant pulmonary, cardiovascular, renal, hepatobiliary or neurological diseases, or another disease process that the investigator feel would put the subject at risk of an adverse event.
  • Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
  • Inability or unwillingness of a participant to give written informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868842

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Lawrence B. Schwartz, M.D., Ph.D Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00868842     History of Changes
Other Study ID Numbers: HM10870, AADCRC-VCU-01
Study First Received: March 23, 2009
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Penicillin
Allergy
Prevention
Anaphylaxis
Clinically proven history of penicillin allergy
preventing anaphylaxis

Additional relevant MeSH terms:
Anaphylaxis
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014