A Comparison of microRNA Samples in Patients With Nasal Polyps and Aspirin Exacerbated Respiratory Disease and Those With Nasal Polyps Only
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ClinicalTrials.gov Identifier: NCT01631773 |
Recruitment Status :
Completed
First Posted : June 29, 2012
Last Update Posted : October 7, 2014
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Condition or disease | Intervention/treatment |
---|---|
Aspirin-exacerbated Respiratory Disease Nasal Polyp | Genetic: microRNA |
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 |
Group/Cohort | Intervention/treatment |
---|---|
subjects w/ Nasal polyps & AERD disease
subjects with nasal polyps and Aspirin-exacerbated respiratory disease (AERD) disease
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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)
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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. |
- Positibe Group: 2 fold or greater will be identified as differntially expressed MiRNA. [ Time Frame: No time frame noted ]5 total groups
- Negative Group: MiRNAs are absent from both groups [ Time Frame: No time frame noted ]5 total groups
Biospecimen Retention: Samples With DNA

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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 |
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.

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
United States, Florida | |
USF Division of Allergy and Clinical Immunology Clinical Research Unit | |
Tampa, Florida, United States, 33613 |
Principal Investigator: | Dennis Ledford, MD | Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine |
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 |
Aspirin-exacerbated respiratory disease Nasal polyp |
Respiration Disorders Respiratory Tract Diseases Nasal Polyps Polyps |
Pathological Conditions, Anatomical Nose Diseases Otorhinolaryngologic Diseases |