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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00594802
Other study ID # systemic reaction protocol
Secondary ID
Status Completed
Phase N/A
First received January 4, 2008
Last updated August 5, 2010
Start date August 2006
Est. completion date June 2007

Study information

Verified date July 2008
Source University of South Florida
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Allergy skin tests and allergen immunotherapy are common procedures for both the diagnosis and treatment of atopic diseases. Allergen immunotherapy has proved to be effective in reducing the symptoms of allergic rhinitis and asthma1-2. Despite its clinical benefit, there is risk of systemic reactions associated with these procedures.

The systemic reaction rate to skin testing for aeroallergens is significant lower than the rate of reactions to immunotherapy, but it is not negligible. Lin et al reported only 2 patients who had systemic allergic reactions to skin testing for respiratory allergies in 10,400 patients tested.3 They determined the overall risk of inducing anaphylactic reactions by skin testing to be less than 0.02% and other studies have produced similar results.4-5 The rate of systemic reactions to skin testing is likely underscored. Thompson et. al reported a systemic reaction rate of 6% of patients receiving skin testing.6 It is important to recognize the risk of systemic reactions seeing skin testing is commonly done. It is also imperative to recognize the treatments for these reactions to prevent progression.

Hypothesis The systemic reaction rate to allergen immunotherapy and skin testing to aeroallergens is higher than previously reported. Biphasic anaphylactic reactions rarely occur with allergen immunotherapy and skin testing.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Male and female subjects who are receiving skin testing or allergen immunotherapy from one allergy practice.

Exclusion Criteria:

- NON Male and female subjects who are receiving skin testing or allergen immunotherapy from one allergy practice.

Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States USF Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary This is a prospective observational study of patients who are having either skin testing or allergen immunotherapy for the diagnosis or treatment of allergic rhinitis, conjunctivitis, and/or asthma. UNKNOWN No
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