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| Sponsors and Collaborators: |
Allegheny General Hospital Pennsylvania Allergy and Asthma Research Foundation |
|---|---|
| Information provided by: | Allegheny General Hospital |
| ClinicalTrials.gov Identifier: | NCT00405899 |
Purpose
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 |
|---|
|
Allergy Seasonal Allergic Rhinitis Perennial Allergic Rhinitis |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections |
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | December 2010 |
| Groups/Cohorts |
|---|
|
Immunotherapy
Patients starting immunotherapy
|
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Non-immunotherapy
Patients being treated using methods other than immunotherapy
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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.
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Male and Female patients aged 6 to 18 years being treated for allergies.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jennifer Koehrsen, MS | 412-359-6988 | jkoehrse@wpahs.org |
| Contact: Timothy Schaffner | 412-359-4043 | tschaffn@wpahs.org |
| United States, Pennsylvania | |
| Allegheny General Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Contact: Jennifer Koehrsen, MS, CCRC 412-359-6988 jkoehrse@wpahs.org | |
| Principal Investigator: Deborah Gentile, MD | |
| Principal Investigator: | Deborah Gentile, MD | Allegheny General Hospital |
More Information
| Responsible Party: | Allegheny General Hospital ( Deborah Gentile/Principal Investigator ) |
| Study ID Numbers: | RC - 4064 |
| Study First Received: | November 28, 2006 |
| Last Updated: | January 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00405899 |
| Health Authority: | United States: Institutional Review Board |
|
Allergy Seasonal Allergic Rhinitis Perennial Allergic Rhinitis |
|
Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Diseases Rhinitis, Allergic, Perennial Respiratory Tract Infections |
Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Rhinitis Respiratory Hypersensitivity |
|
Immune System Diseases Infection Nose Diseases |
