Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps

NCT04104594 | Terminated

• 2 other identifiers: 19CH0992019-A01625-52
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Keywords

TNF alpha

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Olfactory Cleft Endoscopic Score

  2 months

• expression rate of TNF-alpha in polyps

  2 months

• dosage of cytokines G-CSF

  2 months

• dosage of cytokines GM-CSF

  2 months

• dosage of cytokines IFN-γ

  2 months

Study Arms (2)

patients with chronic rhinosinusitis with nasal polyps

EXPERIMENTAL

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

Patients with an indication for septoplasty = control group

OTHER

Diagnostic Test: Sniffin Stick Test; Other: nasal outcome test; Biological: dosage of 17 cytokines

Interventions

Sniffin Stick Test 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.

Patients with an indication for septoplasty = control group; patients with chronic rhinosinusitis with nasal polyps

numerical evaluation scale for olfaction OTHER

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

patients with chronic rhinosinusitis with nasal polyps

numerical evaluation scale for nasal obstruction OTHER

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

patients with chronic rhinosinusitis with nasal polyps

nasal outcome test 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

Patients with an indication for septoplasty = control group; patients with chronic rhinosinusitis with nasal polyps

dosage of 17 cytokines 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; patients with chronic rhinosinusitis with nasal polyps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Nasal Polyps; Olfaction Disorders

Interventions

Smell; Sino-Nasal Outcome Test

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Patient Reported Outcome Measures; Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Marie GAVID, MD

  CHU de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: control and patients

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: February 5, 2020
• Primary Completion: July 6, 2021
• Study Completion: July 29, 2021
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)