Effects of Allergic Rhinitis on the Nasal/Sinus Microbiome

NCT ID: NCT01461200

Last Updated: 2014-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-02-29

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 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.

Conditions

Allergic Rhinitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Non allergics

Swab of vestibule and middle meatus of nose

Intervention Type: OTHER

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

allergics

Swab of vestibule and middle meatus of nose

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Naclerio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

10-712-A

Identifier Type: -

Identifier Source: org_study_id