Status:
COMPLETED
Effects of Allergic Rhinitis on the Nasal/Sinus Microbiome
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18-55 years
Brief Summary
The purpose of this study is to find out if the bacteria present in the nose or sinuses of people with seasonal allergies changes during their allergy season. Another purpose of this study is to see i...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Males and females between 18 and 55 years of age.
- History of tree and/or grass allergic rhinitis for at least 2 years (allergic subjects) or no allergy history at all (normal controls).
- For allergic subjects, a positive skin test to trees and/or grass antigen within prior 12 months. For non-allergic subjects, negative skin tests to common allergens in the Chicago area.
- Exclusion Criteria
- Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.
- Use of nasal steroids, antihistamines in the last 4 weeks.
- Upper respiratory infection, sinusitis less than 2 weeks before screening.
- Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days).
- Participation in other investigational therapy in the last 30 days.
- Any systemic disorder or medication interfering with the study.
- Undergoing allergen desensitization therapy.
- Not willing to give informed consent
- Inability to understand the nature and requirements of the study, or to comply with the study procedures.
- Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Exclusion
Key Trial Info
Start Date :
March 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01461200
Start Date
March 1 2011
End Date
February 1 2012
Last Update
March 27 2014
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637