NCT00405899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2006

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 31, 2010

Status Verified

May 1, 2010

First QC Date

November 28, 2006

Last Update Submit

May 28, 2010

Conditions

AllergySeasonal Allergic RhinitisPerennial Allergic Rhinitis

Keywords

AllergySeasonal Allergic RhinitisPerennial Allergic Rhinitis

Study Arms (2)

Immunotherapy

Patients starting immunotherapy

Non-immunotherapy

Patients being treated using methods other than immunotherapy

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male and Female patients aged 6 to 18 years being treated for allergies.

You may qualify if:

  • 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

You may not qualify if:

  • Concurrent difficult to control asthma or an underlying immune deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

HypersensitivityRhinitis, Allergic, SeasonalRhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Immune System DiseasesRhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, Immediate

Study Officials

  • Deborah Gentile, MD

    West Penn Allegheny Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 30, 2006

Study Start

October 1, 2006

Study Completion

December 1, 2009

Last Updated

May 31, 2010

Record last verified: 2010-05

Locations

US(1)