Effects of Allergic Rhinitis on the Nasal/Sinus Microbiome

Allergic Rhinitis Clinical Trial

Official title:

A Parallel Group Observational Study of the Effects of Allergic Rhinitis on the Nasal/Sinus Microbiome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461200
• Other study ID #: 10-712-A
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: March 26, 2014
• Start date: March 2011
• Est. completion date: February 2012

Study information

• Verified date: March 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 if the bacteria present in the nose and sinuses of non-allergic people are the same as allergic people before the allergy season and if it changes during the season. Many bacteria are difficult to grow in the laboratory so the investigators are using analysis of DNA (the genetic material in cells) of the bacteria in the nose and sinus to find them. The investigators will be testing DNA of the bacteria only and not of the human subjects taking part in this study. This research is being done to help us understand how allergy affects bacteria in the nose and sinuses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria

1. Males and females between 18 and 55 years of age.

2. History of tree and/or grass allergic rhinitis for at least 2 years (allergic subjects) or no allergy history at all (normal controls).

3. 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

1. Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.

2. Use of nasal steroids, antihistamines in the last 4 weeks.

3. Upper respiratory infection, sinusitis less than 2 weeks before screening.

4. Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days).

5. Participation in other investigational therapy in the last 30 days.

6. Any systemic disorder or medication interfering with the study.

7. Undergoing allergen desensitization therapy.

8. Not willing to give informed consent

9. Inability to understand the nature and requirements of the study, or to comply with the study procedures.

10. 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Other:
• Swab of vestibule and middle meatus of nose
Swabs of vestibule and middle meatus of nose will be taken prior to and during the grass/tree allergy season

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bacterial profile of the sinuses	DNA isolation to determine the bacterial profiles of samples taken at baseline (out of subjects' allergy season) and 1 to 3 months later during subjects' allergy season.	Measured at baseline and 1 to 3 months later.	No