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NCT00405899 Clinical Trial

Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections

Allergy Clinical Trial

Official title:
Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00405899
Other study ID # RC - 4064
Secondary ID
Status Completed
Phase N/A
First received November 28, 2006
Last updated May 28, 2010
Start date October 2006
Est. completion date December 2009

Study information
Verified date May 2010
Source West Penn Allegheny Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 18 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Allegheny General Hospital Pittsburgh Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
West Penn Allegheny Health System Pennsylvania Allergy and Asthma Research Foundation

Country where clinical trial is conducted

United States, 

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