Aspirin-exacerbated Respiratory DiseaseNCT01631773
A Comparison of microRNA Samples in Patients With Nasal Polyps and Aspirin Exacerbated Respiratory Disease and Those With Nasal Polyps Only
An observational study of Aspirin-exacerbated Respiratory Disease and Nasal Polyp, run by University of South Florida at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Aspirin-exacerbated Respiratory Disease, Nasal Polyp
- What is being tested?
- microRNA
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
USF Division of Allergy and Clinical Immunology Clinical Research Unit
Tampa, Florida, 33613
About this study
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).
Read the 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.
- Being tested
- microRNA
- Keywords
- Aspirin-exacerbated respiratory disease, Nasal polyp
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microRNAGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| subjects w/ Nasal polyps & AERD disease | subjects with nasal polyps and Aspirin-exacerbated respiratory disease (AERD) disease Receives: Genetic: microRNA | |
| subjects w/ nasal polyps without AERD | subjects with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD) Receives: Genetic: microRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positibe Group: 2 fold or greater will be identified as differntially expressed MiRNA.
5 total groups
Measured: No time frame noted
Negative Group: MiRNAs are absent from both groups
5 total groups
Measured: No time frame noted
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspirin-exacerbated Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Ledford, University of South Florida
- Investigators
- Dennis Ledford, MD, Principal investigator, Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631773
- Sponsor's protocol ID
- Nasal Polyp Study & Aspirin
- Status last verified
- Oct 2014
- First submitted
- 27 Jun 2012
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of microRNA Samples in Patients With Nasal Polyps and Aspirin Exacerbated Respiratory Disease and Those With Nasal Polyps Only
- ClinicalTrials.gov ID
- NCT01631773
- Acronym / sponsor ID
- Nasal Polyp Study & Aspirin
- Keywords
- Aspirin-exacerbated respiratory disease, Nasal polyp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subjects w/ Nasal polyps & AERD disease | – | Genetic: microRNAsubjects with nasal polyps and Aspirin-exacerbated respiratory disease (AERD) disease |
| subjects w/ nasal polyps without AERD | – | Genetic: microRNAsubjects with nasal polyps but without Aspirin-exacerbated respiratory disease (AERD) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microRNABiological 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. | Genetic | subjects w/ Nasal polyps & AERD disease, subjects w/ nasal polyps without AERD |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Ledford, MD principal investigator
Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspirin-exacerbated Respiratory Disease and Nasal Polyp, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positibe Group: 2 fold or greater will be identified as differntially expressed MiRNA. (time frame: No time frame noted). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2014.