Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps

Nasal Polyps Clinical Trial

— OIPN  

Official title:

Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04104594
• Other study ID #: 19CH099
• Secondary ID: 2019-A01625-52
• Status: Terminated
• Phase: N/A
• Start date: February 5, 2020
• Est. completion date: July 29, 2021

Study information

• Verified date: October 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 29, 2021
• Est. primary completion date: July 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Inflammation
• Nasal Polyps
• Olfaction Disorders
• Polyps
• Sinusitis

Intervention

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)
• numerical evaluation scale for nasal obstruction
numerical rating scale from 0 (no freedom of the nasal passages) to 10 (maximum nasal freedom)
• 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-?, IL-1ß, 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-1ß,TNF-a

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	expression rate of TNF-alpha in polyps	measured at control and patients.	2 months
Secondary	dosage of cytokines G-CSF	measured at control and patients.	2 months
Secondary	dosage of cytokines GM-CSF	measured at control and patients.	2 months
Secondary	dosage of cytokines IFN-?	measured at control and patients.	2 months
Secondary	dosage of cytokines IL-1ß, 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
Secondary	dosage of cytokines MCP-1	measured at control and patients.	2 months
Secondary	dosage of cytokines MIP-1ß	measured at control and patients.	2 months
Secondary	dosage of cytokines MCAF	measured at control and patients.	2 months