Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps (OIPN)

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.

Study Overview

• Status: Terminated
• Conditions: Nasal Polyps; Chronic Rhinosinusitis With Nasal Polyps; Olfaction Disorders
• Intervention / Treatment: Diagnostic test: Sniffin Stick Test; Other: numerical evaluation scale for olfaction; Other: numerical evaluation scale for nasal obstruction; Other: nasal outcome test; Biological: dosage of 17 cytokines

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria for patients :

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

Inclusion Criteria for control group :

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

Exclusion Criteria for patients :

• 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.

Exclusion Criteria for control group :

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with chronic rhinosinusitis with nasal polyps	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
Other: Patients with an indication for septoplasty = control group	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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
expression rate of TNF-alpha in biopsies	The main evaluation criterion is based on two variables: the expression rate of TNF-alpha in olfactory slit biopsies and the Sniffin Stick test score.	2 months
Sniffin Stick test score	The main evaluation criterion is based on two variables: the expression rate of TNF-alpha in olfactory slit biopsies and the Sniffin Stick test score. Sniffin Stick test score : The final score, out of 48, is the sum of the olfactory threshold (out of 16), discrimination (out of 16) and identification (out of 16) 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.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Olfactory Cleft Endoscopic Score	measured at control and patients. 5 endoscopic feature to be completed : discharge : 0= none or scant clear/thin drainage (normal) ; 1= more abundant, thicker clear/white drainage (not normal but not purulent) ; 2= thicker, more abundant, discolored/purulent drainage.; polyps : 0= none ; 1= discrete polyps partially narrowing/blocking the olfactory cleft (<50%) ; 2= discrete polyps completely narrowing/blocking the olfactory cleft (>50%).; edema : 0= none ; 1= swelling partially narrowing/blocking the olfactory cleft (<50%) ; 2= swelling completely narrowing/blocking the olfactory cleft (>50%).; crusting : 0= none ; 1= mild ; 2= severe; scarring : 0= none ; 1= mild ; 2= severe	2 months
expression rate of TNF-alpha in polyps	measured at control and patients.	2 months
dosage of cytokines G-CSF	measured at control and patients.	2 months
dosage of cytokines GM-CSF	measured at control and patients.	2 months
dosage of cytokines IFN-γ	measured at control and patients.	2 months
dosage of cytokines IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A	measured at control and patients.	2 months
dosage of cytokines MCP-1	measured at control and patients.	2 months
dosage of cytokines MIP-1β	measured at control and patients.	2 months
dosage of cytokines MCAF	measured at control and patients.	2 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Marie GAVID, MD, CHU de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Actual): July 6, 2021
• Study Completion (Actual): July 29, 2021

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: TNF alpha
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Sensation Disorders; Inflammation; Sinusitis; Nasal Polyps; Polyps; Olfaction Disorders
• Other Study ID Numbers: 19CH099; 2019-A01625-52 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No