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Completed

NCT Number: NCT01631773

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).

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Key information

Conditions

Aspirin-exacerbated Respiratory Disease Nasal Polyp Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

USF Division of Allergy and Clinical Immunology Clinical Research Unit

Tampa, Florida, 33613, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: No time frame noted

    5 total groups

  2. Negative Group: MiRNAs are absent from both groups

    Time frame: No time frame noted

    5 total groups

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 29, 2012
Registry last updated
Oct 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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