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Systemic Reactions to Allergen Immunotherapy Amd Skin Testing (chackos)

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ClinicalTrials.gov Identifier: NCT00594802
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : August 9, 2010
Sponsor:
Information provided by:
University of South Florida

Study Description
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Brief 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.


Condition or disease
SYSTEMIC REACTION

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Retrospective
Official Title: Systemic Reactions to Allergen Immunotherapy Amd Skin Testing
Study Start Date : August 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007
Groups and Cohorts
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Group/Cohort
CHART REVIEW ONLY
CHART REVIEW OF PATIENTS WITH SYSTEMIC REACTIONS


Outcome Measures
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Primary Outcome Measures :
  1. 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.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: August 9, 2010
Last Verified: July 2008

Keywords provided by University of South Florida:
ALLERGIC REACTION