NCT04104594

Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Impaired olfaction is one of the major complaints of patients with nasosinus polyposis, with nasal obstruction. In case of failure of medical treatment for patients with polyposis nasosinusal, they may use endoscopic surgery nasosinusal. Before surgery, 73% are hyposmic or anosmic, compared to 43% after surgery. Persistence of hyposmia or anosmia despite the removal of polyps can be explained by mechanisms inflammatory in the mucous membrane of the olfactory cleft. In addition, studies in mice have shown a degeneration of primary olfactory neurons at the level of the olfactory mucosa in connection with directly with TNF alpha, a pro-inflammatory molecule.

Conditions

• Nasal Polyps
• Chronic Rhinosinusitis With Nasal Polyps
• Olfaction Disorders

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Sniffin Stick Test	The test consists of odorous rods that are presented to the patient's nose. It consists of 3 parts different, with 3 sets of corresponding sticks: an olfactory threshold test, an olfactory discrimination test and an olfactory identification test. The final score, out of 48, is the sum of the olfactory threshold, discrimination and identification scores. Normal test values are defined as greater than the tenth percentile of the general population, so the test result is compared to reference values on a chart to determine whether the patient is normosmic, hyposmic or anosmic.
OTHER	numerical evaluation scale for olfaction	numerical rating scale from 0 (no smell) to 10 (perfect smell)
OTHER	numerical evaluation scale for nasal obstruction	numerical rating scale from 0 (no freedom of the nasal passages) to 10 (maximum nasal freedom)
OTHER	nasal outcome test	list of symptoms and social/emotional consequences of rhino-sinusitis. 16 questions that the patient must code from "no problem" to "serious problem" over the last 15 days
BIOLOGICAL	dosage of 17 cytokines	dosage of 17 cytokines : G-CSF, GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 (p70), IL-13, IL-17A, MCP-1 (MCAF), MIP-1β,TNF-α

Timeline

• Start date: 2020-02-05
• Primary completion: 2021-07-06
• Completion: 2021-07-29
• First posted: 2019-09-26
• Last updated: 2022-10-25

Locations

1 site across 1 country: France