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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dennis Ledford, University of South Florida
ClinicalTrials.gov Identifier:
NCT01631773
First received: June 27, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted

June 27, 2012
June 27, 2012
August 2011
June 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
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.

Non-Probability Sample

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.

  • Aspirin-exacerbated Respiratory Disease
  • Nasal Polyp
Genetic: microRNA
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.
  • subjects w/ Nasal polyps & AERD disease
    subjects with nasal polyps and Aspirin-exacerbated respiratory disease (AERD) disease
    Intervention: Genetic: microRNA
  • subjects w/ nasal polyps without AERD
    subjects with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD)
    Intervention: Genetic: microRNA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01631773
Nasal Polyp Study & Aspirin
Yes
Dennis Ledford, University of South Florida
University of South Florida
Not Provided
Principal Investigator: Dennis Ledford, MD Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine
University of South Florida
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP