RhinosinusitisODORNCT00797004
Olfactory Dysfunction of Rhinosinusitis
An observational study of Rhinosinusitis, run by Greg Davis at 1 site in United States.
Trial summary
The purpose of this research is to improve understanding of the molecular and functional properties of the human olfactory system. The specific aims are: to determine the location of AC3 and Golf proteins in the human olfactory epithelium from freshly harvested nasal/sinus tissue of surgical patients to perform… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinosinusitis
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Sep 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: surgical patients from the UW Otolaryngology - Head and Neck surgery clinic
Who may be able to join
- over 18 yrs. of age, scheduled for: a.) endoscopic sinus surgery for chronic sinusitis, b.) endoscopic transnasal approach to the pituitary for pituitary tumor removal, c.) endoscopic inferior turbinectomy for nasal congestion d.)endoscopic repair of cerebrospinal fluid leaks
Who cannot join
- unable to give informed consent or complete questionnaires due to language, cognitive impairment or sever medical conditions.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
The purpose of this research is to improve understanding of the molecular and functional properties of the human olfactory system.
The specific aims are:
- to determine the location of AC3 and Golf proteins in the human olfactory epithelium from freshly harvested nasal/sinus tissue of surgical patients
- to perform objective functional studies on fresh human nasal/sinus tissue using an electro-olfactogram (EOG) whic measures the electrical activity of olfactory sensory neurons in fresh biopsied tissue in response to odor or pheromone stimulation. An organotypic culture system for human tissue has been established to optimize the electrical signal acquisition.
- to correlate the AC3 and Golf expression profiles with pre-operative testing of human olfactory function
- to correlate the EOG findings with pre-operative testing of human olfactory function.
- to systematically evaluate the role of individual intranasal agents on olfaction to further optimize the electrical signal acquisition from olfactory tissue.
Read the detailed description
This is a prospective cohort study. Subjects will be recruited from the group of patients at the University of Washington Otolaryngology-Head and Neck Surgery Clinic who will undergo endoscopic sinus surgery for chronic sinusitis and other disorders of the nasal cavity and sinuses.
Subjects will sign consent and complete a subjective smell test (UPSIT--University of Pennsylvania Smell Identification Test), and the SNOT-20 (Sinonasal Outcome Test-20)
During their surgery, subjects will have two to four pieces of normally discarded tissue preserved for the study. Subjects will also have two to four pieces of healthy tissue removed (total size approximately that of a pencil eraser tip)depending on the type of surgery involved. The following procedures will be performed on these tissues:
- immunocytochemistry utilizing antibodies to AC3 and Golf to determine the patterns and levels of expression of these proteins
- two odorants, isoamyl acetate and citralva, to elicit odorant-induced activity from the human olfactory sensory neurons. The tissue will also be subjected to two putative human pheromones: 4,16-androstadiene-3-ol and 1,3,5(10),16-estrateraen-3-ol.
- application of six commonly used intranasal agents: 0.9% saline, 1:1000,000 epinephrine, 0.05% oxymetazoline, 1% lidocaine, Zicam (0.12% zinc gluconate) and Nasocort AQ (triamcinolone acetate).
- Conditions
- Rhinosinusitis
- Keywords
- olfactory dysfunction
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| endoscopic sinus procedure candidates | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhinosinusitisStudies of the same condition, open and under way.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greg Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Greg Davis, University of Washington
- Investigators
- Greg E Davis, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797004
- Sponsor's protocol ID
- 35031-B
- Acronym
- ODOR
- Status last verified
- Jun 2012
- First submitted
- 21 Nov 2008
- Last updated
- 29 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lim JH, Davis GE, Rue TC, Storm DR. Human sinonasal explant system for testing cytotoxicity of intranasal agents. Int Forum Allergy Rhinol. 2012 Jan-Feb;2(1):63-8. doi: 10.1002/alr.20110. Epub 2011 Dec 13.
PubMed 22170775
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Dysfunction of Rhinosinusitis
- ClinicalTrials.gov ID
- NCT00797004
- Acronym / sponsor ID
- ODOR / 35031-B
- Conditions
- Rhinosinusitis
- Keywords
- olfactory dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Greg DavisUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 24 Nov 2008 (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.
The purpose of this research is to improve understanding of the molecular and functional properties of the human olfactory system.
The specific aims are:
- to determine the location of AC3 and Golf proteins in the human olfactory epithelium from freshly harvested nasal/sinus tissue of surgical patients
- to perform objective functional studies on fresh human nasal/sinus tissue using an electro-olfactogram (EOG) whic measures the electrical activity of olfactory sensory neurons in fresh biopsied tissue in response to odor or pheromone stimulation. An organotypic culture system for human tissue has been established to optimize the electrical signal acquisition.
- to correlate the AC3 and Golf expression profiles with pre-operative testing of human olfactory function
- to correlate the EOG findings with pre-operative testing of human olfactory function.
- to systematically evaluate the role of individual intranasal agents on olfaction to further optimize the electrical signal acquisition from olfactory tissue.
Detailed description
This is a prospective cohort study. Subjects will be recruited from the group of patients at the University of Washington Otolaryngology-Head and Neck Surgery Clinic who will undergo endoscopic sinus surgery for chronic sinusitis and other disorders of the nasal cavity and sinuses.
Subjects will sign consent and complete a subjective smell test (UPSIT--University of Pennsylvania Smell Identification Test), and the SNOT-20 (Sinonasal Outcome Test-20)
During their surgery, subjects will have two to four pieces of normally discarded tissue preserved for the study. Subjects will also have two to four pieces of healthy tissue removed (total size approximately that of a pencil eraser tip)depending on the type of surgery involved. The following procedures will be performed on these tissues:
- immunocytochemistry utilizing antibodies to AC3 and Golf to determine the patterns and levels of expression of these proteins
- two odorants, isoamyl acetate and citralva, to elicit odorant-induced activity from the human olfactory sensory neurons. The tissue will also be subjected to two putative human pheromones: 4,16-androstadiene-3-ol and 1,3,5(10),16-estrateraen-3-ol.
- application of six commonly used intranasal agents: 0.9% saline, 1:1000,000 epinephrine, 0.05% oxymetazoline, 1% lidocaine, Zicam (0.12% zinc gluconate) and Nasocort AQ (triamcinolone acetate).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endoscopic sinus procedure candidates | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- surgical patients from the UW Otolaryngology - Head and Neck surgery clinic
Key inclusion criteria (1 listed)
- over 18 yrs. of age, scheduled for: a.) endoscopic sinus surgery for chronic sinusitis, b.) endoscopic transnasal approach to the pituitary for pituitary tumor removal, c.) endoscopic inferior turbinectomy for nasal congestion d.)endoscopic repair of cerebrospinal fluid leaks
Key exclusion criteria (1 listed)
- unable to give informed consent or complete questionnaires due to language, cognitive impairment or sever medical conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 29 Jun 2012.
- Results publication: PubMed 22170775Lim JH, Davis GE, Rue TC, Storm DR. Human sinonasal explant system for testing cytotoxicity of intranasal agents. Int Forum Allergy Rhinol. 2012 Jan-Feb;2(1):63-8. doi: 10.1002/alr.20110. Epub 2011 Dec 13.
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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.
Greg E Davis, MD, MPH principal investigator
University of Washington
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 Rhinosinusitis, run by Greg Davis 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 1 inclusion and 1 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 29 Jun 2012. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00797004, which also lists 1 linked publication.
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 29 Jun 2012.