NCT00594802

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
Last Updated

August 9, 2010

Status Verified

July 1, 2008

Enrollment Period

10 months

First QC Date

January 4, 2008

Last Update Submit

August 5, 2010

Conditions

Keywords

ALLERGIC REACTION

Outcome Measures

Primary Outcomes (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.

Study Arms (1)

CHART REVIEW ONLY

CHART REVIEW OF PATIENTS WITH SYSTEMIC REACTIONS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USF

Tampa, Florida, 33613, United States

Location

Related Publications (1)

  • Bagg A, Chacko T, Lockey R. Reactions to prick and intradermal skin tests. Ann Allergy Asthma Immunol. 2009 May;102(5):400-2. doi: 10.1016/S1081-1206(10)60511-X.

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • RICHARD F LOCKEY, MD

    USF DIRECTOR OF ALLERGY AND IMMUNOLOGY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 16, 2008

Study Start

August 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

August 9, 2010

Record last verified: 2008-07

Locations