Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01631773
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Dennis Ledford, University of South Florida

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment
Aspirin-exacerbated Respiratory Disease Nasal Polyp Genetic: microRNA

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.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparison of microRNA Samples in Patients With Nasal Polyps and Aspirin Exacerbated Respiratory Disease and Those With Nasal Polyps Only
Study Start Date : August 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
subjects w/ Nasal polyps & AERD disease
subjects with nasal polyps and Aspirin-exacerbated respiratory disease (AERD) disease
 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 without AERD
subjects with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD)
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631773


Locations
Layout table for location information
United States, Florida
USF Division of Allergy and Clinical Immunology Clinical Research Unit
Tampa, Florida, United States, 33613
Sponsors and Collaborators
University of South Florida
Investigators
Layout table for investigator information
Principal Investigator: Dennis Ledford, MD Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dennis Ledford, Principal Investigator, University of South Florida
ClinicalTrials.gov Identifier: NCT01631773    
Other Study ID Numbers: Nasal Polyp Study & Aspirin
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: October 2014
Keywords provided by Dennis Ledford, University of South Florida:
Aspirin-exacerbated respiratory disease
Nasal polyp
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiration Disorders
Respiratory Tract Diseases
Nasal Polyps
Polyps
 Pathological Conditions, Anatomical
Nose Diseases
Otorhinolaryngologic Diseases