A Comparison of microRNA Samples in Patients With Nasal Polyps and Aspirin Exacerbated Respiratory Disease and Those With Nasal Polyps Only

Completed

• Conditions: Aspirin-exacerbated Respiratory Disease; Nasal Polyp
• Interventions: Genetic: microRNA

• Registration Number: NCT01631773
• Lead Sponsor: University of South Florida

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 Timeline

• Study Start: 2011-08
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2012-06-27
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-29
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-06
• Last Update Posted: 2014-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
subjects w/ Nasal polyps & AERD disease	microRNA	subjects with nasal polyps and Aspirin-exacerbated respiratory disease (AERD) disease
subjects w/ nasal polyps without AERD	microRNA	subjects with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD)

Primary Outcome Measures

Name	Time	Method
Negative Group: MiRNAs are absent from both groups	No time frame noted	5 total groups
Positibe Group: 2 fold or greater will be identified as differntially expressed MiRNA.	No time frame noted	5 total groups

Trial Locations

Locations (1)

USF Division of Allergy and Clinical Immunology Clinical Research Unit; 🇺🇸 Tampa, Florida, United States