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Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections

This study has been completed.
Sponsor:
Collaborator:
Pennsylvania Allergy and Asthma Research Foundation
Information provided by:
West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT00405899
First received: November 28, 2006
Last updated: May 28, 2010
Last verified: May 2010
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections

Resource links provided by NLM:


Further study details as provided by West Penn Allegheny Health System:

Estimated Enrollment: 20
Study Start Date: October 2006
Study Completion Date: December 2009
Groups/Cohorts
Immunotherapy
Patients starting immunotherapy
Non-immunotherapy
Patients being treated using methods other than immunotherapy

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

Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and Female patients aged 6 to 18 years being treated for allergies.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405899

Locations
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
West Penn Allegheny Health System
Pennsylvania Allergy and Asthma Research Foundation
Investigators
Principal Investigator: Deborah Gentile, MD West Penn Allegheny Health System
  More Information

Responsible Party: Deborah Gentile/Principal Investigator, Allegheny General Hospital
ClinicalTrials.gov Identifier: NCT00405899     History of Changes
Other Study ID Numbers: RC - 4064
Study First Received: November 28, 2006
Last Updated: May 28, 2010

Keywords provided by West Penn Allegheny Health System:
Allergy
Seasonal Allergic Rhinitis
Perennial Allergic Rhinitis

Additional relevant MeSH terms:
Rhinitis
Hypersensitivity
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Respiratory Tract Infections
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Immune System Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Infection

ClinicalTrials.gov processed this record on September 21, 2017