Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections

Sponsor

West Penn Allegheny Health System (Other)

Overall Status

Completed

CT.gov ID

NCT00405899

Collaborator

Pennsylvania Allergy and Asthma Research Foundation (Other)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Allergy Seasonal Allergic Rhinitis Perennial Allergic Rhinitis

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections

Study Start Date :

Oct 1, 2006

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Immunotherapy Patients starting immunotherapy
Non-immunotherapy Patients being treated using methods other than immunotherapy

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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