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Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections

NCT ID: NCT00405899

Last Updated: 2010-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Allergy Seasonal Allergic Rhinitis Perennial Allergic Rhinitis

Keywords

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Allergy Seasonal Allergic Rhinitis Perennial Allergic Rhinitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Immunotherapy

Patients starting immunotherapy

No interventions assigned to this group

Non-immunotherapy

Patients being treated using methods other than immunotherapy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pennsylvania Allergy and Asthma Research Foundation

UNKNOWN

Sponsor Role collaborator

West Penn Allegheny Health System

OTHER

Sponsor Role lead

Responsible Party

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Allegheny General Hospital

Principal Investigators

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Deborah Gentile, MD

Role: PRINCIPAL_INVESTIGATOR

West Penn Allegheny Health System

Locations

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Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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RC - 4064

Identifier Type: -

Identifier Source: org_study_id