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

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University of South Florida

Status

Completed

Conditions

Nasal Polyp
Aspirin-exacerbated Respiratory Disease

Treatments

Genetic: microRNA

Study type

Observational

Funder types

Other

Identifiers

NCT01631773
Nasal Polyp Study & Aspirin

Details and patient eligibility

About

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).

Full 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.

Enrollment

26 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

26 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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