Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps

NCT ID: NCT04104594

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-05
• Study Completion Date: 2021-07-29

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

patients with chronic rhinosinusitis with nasal polyps

Group Type: EXPERIMENTAL

Sniffin Stick Test

Intervention Type: DIAGNOSTIC_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.

numerical evaluation scale for olfaction

Intervention Type: OTHER

numerical rating scale from 0 (no smell) to 10 (perfect smell)

numerical evaluation scale for nasal obstruction

Intervention Type: OTHER

numerical rating scale from 0 (no freedom of the nasal passages) to 10 (maximum nasal freedom)

nasal outcome test

Intervention Type: OTHER

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

dosage of 17 cytokines

Intervention Type: BIOLOGICAL

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

Patients with an indication for septoplasty = control group

Group Type: OTHER

Sniffin Stick Test

Intervention Type: DIAGNOSTIC_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.

nasal outcome test

Intervention Type: OTHER

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

dosage of 17 cytokines

Intervention Type: BIOLOGICAL

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

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

numerical evaluation scale for olfaction

numerical rating scale from 0 (no smell) to 10 (perfect smell)

Intervention Type: OTHER

numerical evaluation scale for nasal obstruction

numerical rating scale from 0 (no freedom of the nasal passages) to 10 (maximum nasal freedom)

Intervention Type: 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

Intervention Type: OTHER

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients with nasosinus polyposis requiring nasosinus surgery
• Patient affiliated or entitled to a social security
• signed consent

• Patients with an indication for septoplasty
• Patient affiliated or entitled to a social security
• signed consent

Exclusion Criteria

• Patients with nasosinus polyposis secondary to another disease
• Patients with hyposmia or anosmia prior to naso-sinus polyposis
• Patients with diagnosed neurodegenerative disease
• Patients who are mentally or physically unable to perform olfactory tests
• Patients on anti-TNF-alpha therapy, long-term oral corticosteroid therapy, or other immunomodulatory therapy.

• Patients with nasosinus polyposis
• Patients with chronic rhino-sinusitis
• Patients with hyposmia or anosmia
• Patients with diagnosed neurodegenerative disease
• Patients who are mentally or physically unable to perform olfactory tests
• Patients on anti-TNF-alpha therapy, long-term oral corticosteroid therapy, or other immunomodulatory therapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie GAVID, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint Etienne

Locations

Chu Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2019-A01625-52

Identifier Type: OTHER

Identifier Source: secondary_id

19CH099

Identifier Type: -

Identifier Source: org_study_id