Clinical trial NCT01631773: A Comparison of microRNA Samples in Patients With Nasal Polyps and Aspirin Exacerbated Respiratory Disease and Those With Nasal Polyps Only
Official title: A Comparison of microRNA Samples in Patients With Nasal Polyps and Aspirin Exacerbated Respiratory Disease and Those With Nasal Polyps Only
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aspirin-exacerbated Respiratory Disease
Nasal Polyp
Keywords: Aspirin-exacerbated respiratory disease
Nasal polyp
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Positibe Group: 2 fold or greater will be identified as differntially expressed MiRNA.
timeFrame: No time frame noted
measure: Negative Group: MiRNAs are absent from both groups
timeFrame: No time frame noted
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF Division of Allergy and Clinical Immunology Clinical Research Unit
state: Florida
Study officials:
affiliation: Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine
name: Dennis Ledford, MD
role: PRINCIPAL_INVESTIGATOR
References: