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

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).

Study Overview

• Status: Completed
• Conditions: Aspirin-exacerbated Respiratory Disease; Nasal Polyp
• Intervention / Treatment: Genetic: microRNA

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 Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33613
      • USF Division of Allergy and Clinical Immunology Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will be a prospective study design with a target sample size of 20. The objective of conducting it as a prospective study is to confirm that the sampling procedures and analysis methodology work as expected before attempting a larger study. We propose to have 10 study participants with nasal polyps but without AERD and 10 study participants with nasal polyps and AERD. If the results of this study are promising, larger studies with sufficient power for statistical analysis will be considered.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
subjects w/ Nasal polyps & AERD disease; subjects with nasal polyps and Aspirin-exacerbated respiratory disease (AERD) disease	Genetic: microRNA; Biological samples will be taken from subjects w/ Nasal polyps & AERD disease and subjects w/ nasal polyps without AERD. MicroRNA will be analyzed to compare genetic similarities and differences between the two study groups.
subjects w/ nasal polyps without AERD; subjects with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD)	Genetic: microRNA; Biological samples will be taken from subjects w/ Nasal polyps & AERD disease and subjects w/ nasal polyps without AERD. MicroRNA will be analyzed to compare genetic similarities and differences between the two study groups.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Dennis Ledford, MD, Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: June 27, 2012
• First Submitted That Met QC Criteria: June 27, 2012
• First Posted (ESTIMATE): June 29, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 7, 2014
• Last Update Submitted That Met QC Criteria: October 6, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Aspirin-exacerbated respiratory disease; Nasal polyp
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Nose Diseases; Nasal Polyps; Polyps; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: Nasal Polyp Study & Aspirin