Olfactory Dysfunction of Rhinosinusitis

Status Completed

Clinical 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 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00797004
Study type	Observational
Source	University of Washington
Contact
Status	Completed
Phase	N/A
Start date	November 2008
Completion date	September 2010

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Olfactory Dysfunction of Rhinosinusitis — ODOR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms