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

NCT01631773 | Completed DMC

• 1 other identifier: Nasal Polyp Study & Aspirin
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Aspirin-exacerbated Respiratory Disease; Nasal Polyp

Keywords

Aspirin-exacerbated respiratory disease; Nasal polyp

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

subjects w/ Nasal polyps & AERD disease

subjects with nasal polyps and Aspirin-exacerbated respiratory disease (AERD) disease

Genetic: microRNA

subjects w/ nasal polyps without AERD

subjects with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD)

Genetic: microRNA

Interventions

microRNA GENETIC

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 & AERD disease; subjects w/ nasal polyps without AERD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

USF Division of Allergy and Clinical Immunology Clinical Research Unit

Tampa, Florida, 33613, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Nasal Polyps

Interventions

MicroRNAs

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RNA, Antisense; Antisense Elements (Genetics); Nucleic Acids, Nucleotides, and Nucleosides; RNA; Nucleic Acids; RNA, Small Untranslated; RNA, Untranslated

Study Officials

• Dennis Ledford, MD

  Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2012
• First Posted: June 29, 2012
• Study Start: August 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 7, 2014

Record last verified: 2014-10

Locations

US (1)