Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405899
Status:
COMPLETED
Last Update Posted:
2010-05-31
First Post:
2006-11-28
Brief Title:
Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections
Sponsor:
West Penn Allegheny Health System
Organization:
West Penn Allegheny Health System
Study Overview
Official Title:
Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 reviewexchange of diary cards and phlebotomy for determination of serial serum interferon-gamma levels
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 reviewexchange of diary cards and phlebotomy for determination of serial serum interferon-gamma levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None