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Systemic Reactions to Allergen Immunotherapy Amd Skin Testing (chackos)

This study has been completed.
Sponsor:
Information provided by:
University of South Florida
ClinicalTrials.gov Identifier:
NCT00594802
First received: January 4, 2008
Last updated: August 5, 2010
Last verified: July 2008
History of Changes
  Purpose

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.


Condition
SYSTEMIC REACTION

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Systemic Reactions to Allergen Immunotherapy Amd Skin Testing

Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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. [ Time Frame: UNKNOWN ] [ Designated as safety issue: No ]
Estimated Enrollment: 100
Study Start Date: August 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
CHART REVIEW ONLY
CHART REVIEW OF PATIENTS WITH SYSTEMIC REACTIONS

  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects who are receiving skin testing or allergen immunotherapy from one allergy practice.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594802

Locations
United States, Florida
USF
Tampa, Florida, United States, 33613
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: RICHARD F LOCKEY, MD USF DIRECTOR OF ALLERGY AND IMMUNOLOGY
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: DR. RICHARD F LOCKEY, UNIVERSITY OF SOUTH FLORIDA
ClinicalTrials.gov Identifier: NCT00594802     History of Changes
Other Study ID Numbers: systemic reaction protocol 
Study First Received: January 4, 2008
Last Updated: August 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
ALLERGIC REACTION

ClinicalTrials.gov processed this record on September 29, 2016