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CompletedNCT01631773Updated Oct 7, 2014

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

An observational study in Aspirin-exacerbated Respiratory Disease and Nasal Polyp, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-10-07.

Sponsored by University of South Florida · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
26
Ages
18 Years to 70 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Aspirin-exacerbated Respiratory Disease
  • Nasal Polyp

Keywords

  • Aspirin-exacerbated respiratory disease
  • Nasal polyp
03

In context

Respiratory Tract Diseases

617 studies on the registry are indexed under Respiratory Tract Diseases; 111 are open to participants now.

This study's enrollment of 26 is below the median of 294 across 216 observational studies indexed under Respiratory Tract Diseases.

Browse Respiratory Tract Diseases studies →

Lead sponsor

University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
26 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • GeneticmicroRNA

    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.

06

What researchers measure

Primary outcomes

  1. Positibe Group: 2 fold or greater will be identified as differntially expressed MiRNA.

    5 total groups

    Time frame: No time frame noted

  2. Negative Group: MiRNAs are absent from both groups

    5 total groups

    Time frame: No time frame noted

07

Study locations

1 site
  • USF Division of Allergy and Clinical Immunology Clinical Research Unit
    Tampa, Florida 33613, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01631773
Lead sponsor
University of South Florida
Responsible party
Dennis Ledford (Principal Investigator, University of South Florida) — Principal investigator
First posted
Jun 29, 2012
Start date
Aug 2011
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Oct 7, 2014

Study contacts

Dennis Ledford, MD
principal investigator · Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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