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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01631773
Enrollment
26
Registered
2012-06-29
Start date
2011-08-31
Completion date
2012-06-30
Last updated
2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspirin-exacerbated Respiratory Disease, Nasal Polyp

Keywords

Aspirin-exacerbated respiratory disease, Nasal polyp

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.

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.

Sponsors

University of South Florida
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Positibe Group: 2 fold or greater will be identified as differntially expressed MiRNA.No time frame noted5 total groups
Negative Group: MiRNAs are absent from both groupsNo time frame noted5 total groups

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026