Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps

NCT04104594 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-10-25

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Marie GAVID, MD · CHU de Saint Etienne

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-05
Primary Completion
2021-07-06
Completion
2021-07-29

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04104594 on ClinicalTrials.gov