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

Anaphylaxis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868842
• Other study ID #: HM10870
• Secondary ID: AADCRC-VCU-01
• Status: Completed
• Phase: N/A
• First received: March 23, 2009
• Last updated: April 10, 2014
• Start date: January 2009
• Est. completion date: June 2012

Study information

• Verified date: April 2014
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anaphylaxis

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased skin test sensitivity to Pre-pen (PC3 value)		June 2012	No