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
  Purpose

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 Intervention
Aspirin-exacerbated Respiratory Disease
Nasal Polyp
Genetic: microRNA

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of South Florida:

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.


Enrollment: 26
Study Start Date: August 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631773

Locations
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
Principal Investigator: Dennis Ledford, MD Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine
  More Information

No publications provided

Responsible Party: Dennis Ledford, Principal Investigator, University of South Florida
ClinicalTrials.gov Identifier: NCT01631773     History of Changes
Other Study ID Numbers: Nasal Polyp Study & Aspirin
Study First Received: June 27, 2012
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Aspirin-exacerbated respiratory disease
Nasal polyp

Additional relevant MeSH terms:
Nasal Polyps
Polyps
Respiration Disorders
Respiratory Tract Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014