Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections
Information source: West Penn Allegheny Health System
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergy; Seasonal Allergic Rhinitis; Perennial Allergic Rhinitis
Phase: N/A
Status: Recruiting
Sponsored by: West Penn Allegheny Health System Official(s) and/or principal investigator(s):
Deborah Gentile, MD, Principal Investigator, Affiliation: West Penn Allegheny Health System
Overall contact:
Jennifer Koehrsen, MS, Phone: 412-359-6988, Email: jkoehrse@wpahs.org
Summary
The objective of this study is to determine whether there is a relationship between
interferon-gamma levels and the incidence of viral respiratory infections in allergic
children treated with allergy immunotherapy as compared to those treated with standard
medical care (nasal steroids, antihistamines) over a 1-year period. The hypotheses to be
tested are 1) interferon-gamma levels will be significantly increased 3, 6, 9 and 12 months
in allergic children treated with allergy immunotherapy as compared to those treated with
standard medical care, 2) the incidence of viral respiratory infections will be reduced at
3, 6, 9 and 12 months in allergic children treated with allergy immunotherapy as compared to
those treated with standard medical care.
Clinical Details
Official title: Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections
Study design: Cohort, Prospective
Detailed description:
This study will consist of five visits. Visit 1 will occur after subjects complete an
initial clinical evaluation for allergy at this site. Subjects will select their treatment
(allergy immunotherapy as compared to standard medical care) prior to enrollment in this
study.
Visit 1 will include informed consent, review of inclusion and exclusion criteria and
phlebotomy for the determination of serum interferon-gamma levels. At the end of this
visit, diary cards to capture the frequency of symptoms of viral respiratory infections will
be distributed. Visits 2-5 will occur 3, 6, 9 and 12 months after visit 1 and will include
review/exchange of diary cards, and phlebotomy for determination of serial serum
interferon-gamma levels.
Eligibility
Minimum age: 6 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 6-18 years of age
- History of allergic rhinitis as confirmed by previous allergy skin testing conducted
within the past year
- Subjects assigned to the allergy immunotherapy must be prescribed therapy according
to national recommendations using FDA-approved allergy extracts supplied by Greer
Laboratories
Exclusion Criteria:
- Concurrent difficult to control asthma or an underlying immune deficiency
Locations and Contacts
Jennifer Koehrsen, MS, Phone: 412-359-6988, Email: jkoehrse@wpahs.org
Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States; Recruiting
Jennifer Koehrsen, MS, CCRC, Phone: 412-359-6988, Email: jkoehrse@wpahs.org
Deborah Gentile, MD, Principal Investigator
Additional Information
Starting date: October 2006
Ending date: December 2010
Last updated: May 28, 2009
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