Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps

Not Applicable

Terminated

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

• Registration Number: NCT04104594
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-26
• Study Start: 2020-02-05
• Primary Completion: 2021-07-06
• Study Completion: 2021-07-29
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-21
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with an indication for septoplasty = control group	nasal outcome test	-
patients with chronic rhinosinusitis with nasal polyps	numerical evaluation scale for olfaction	-
patients with chronic rhinosinusitis with nasal polyps	numerical evaluation scale for nasal obstruction	-
patients with chronic rhinosinusitis with nasal polyps	nasal outcome test	-
Patients with an indication for septoplasty = control group	Sniffin Stick Test	-
Patients with an indication for septoplasty = control group	dosage of 17 cytokines	-
patients with chronic rhinosinusitis with nasal polyps	Sniffin Stick Test	-
patients with chronic rhinosinusitis with nasal polyps	dosage of 17 cytokines	-

Primary Outcome Measures

Name	Time	Method
expression rate of TNF-alpha in biopsies	2 months	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	2 months	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.

Secondary Outcome Measures

Name	Time	Method
dosage of cytokines IFN-γ	2 months	measured at control and patients.
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	2 months	measured at control and patients.
expression rate of TNF-alpha in polyps	2 months	measured at control and patients.
Olfactory Cleft Endoscopic Score	2 months	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
dosage of cytokines G-CSF	2 months	measured at control and patients.
dosage of cytokines GM-CSF	2 months	measured at control and patients.
dosage of cytokines MCP-1	2 months	measured at control and patients.
dosage of cytokines MIP-1β	2 months	measured at control and patients.
dosage of cytokines MCAF	2 months	measured at control and patients.

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Étienne, France