Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections

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.

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Key information

Conditions

Allergy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Perennial Allergic Rhinitis Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal Seasonal Allergic Rhinitis

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

West Penn Allegheny Health System

Other

Collaborators

Pennsylvania Allergy and Asthma Research Foundation

Registry information

Important dates

Study start: 2006
Study completion: 2009
First posted: Nov 30, 2006
Registry last updated: May 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed