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

Aspirin-exacerbated Respiratory Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631773
• Other study ID #: Nasal Polyp Study & Aspirin
• Status: Completed
• Phase: N/A
• First received: June 27, 2012
• Last updated: October 6, 2014
• Start date: August 2011
• Est. completion date: June 2012

Study information

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

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aspirin-exacerbated Respiratory Disease
• Nasal Polyp
• Nasal Polyps
• Polyps
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	USF Division of Allergy and Clinical Immunology Clinical Research Unit	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

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