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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Aspirin-exacerbated Respiratory Disease, Nasal Polyp

Intervention / Treatment
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* Genetic: microRNA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| subjects w/ Nasal polyps & AERD disease<br>subjects with nasal polyps and Aspirin-exacerbated respiratory disease (AERD) disease | Genetic: microRNA<br>* 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.<br>|
| subjects w/ nasal polyps without AERD<br>subjects with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD) | Genetic: microRNA<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aspirin-exacerbated respiratory disease, Nasal polyp