A Comparison of microRNA Samples in Patients With Nasal Polyps and Aspirin Exacerbated Respiratory Disease and Those With Nasal Polyps Only
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of South Florida
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Positibe Group: 2 fold or greater will be identified as differntially expressed MiRNA.
Study Overview
Brief Summary
We hypothesize that the miRNA expression in subjects with nasal polyps and Aspirin-exacerbated respiratory disease (AERD) differs from the miRNA expressed in subjects with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD).
Detailed Description
Nasal epithelial tissue will be collected from the inferior nasal turbinates of ten subjects with nasal polyps and AERD disease and from the inferior turbinates of ten subjects with nasal polyps but without AERD. A rhinoprobe™ will be used to collect this epithelial tissue. These samples will be analyzed by miRNA assay to determine if there is a difference in mircroRNA expression between the two subject groups.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ages eligible for study: 18 to 70 years
- •Genders eligible for study: male and female
- •Signed and dated written informed consent is obtained prior to study
- •Subjects have a physician diagnosis of nasal polyps without AERD or physician diagnosis of nasal polyps with AERD. The diagnosis of aspirin sensitive asthma must be present for a minimum of three months. If the medical history is indeterminate either an aspirin challenge will be required to confirm or rule out the diagnosis. An aspirin challenge is a protocol that can safely be performed as an out patient procedure with close supervision.
Exclusion Criteria
- •Pregnant and/or lactating females.
- •Current tobacco use.
- •Severe psychiatric illness.
- •Current illicit substance use or dependence and/or abuse of alcohol.
- •Primary or secondary immunodeficiency.
- •Any clinically significant uncontrolled medical condition that would put the patient at risk.
Outcomes
Primary Outcomes
Positibe Group: 2 fold or greater will be identified as differntially expressed MiRNA.
Time Frame: No time frame noted
5 total groups
Negative Group: MiRNAs are absent from both groups
Time Frame: No time frame noted
5 total groups
Secondary Outcomes
No secondary outcomes reported
Investigators
Dennis Ledford
Principal Investigator
University of South Florida