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

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Olfaction Disorders; Nasal Polyps; Chronic Rhinosinusitis With Nasal Polyps

Treatments: Other: numerical evaluation scale for nasal obstruction; Biological: dosage of 17 cytokines; Other: nasal outcome test; Other: numerical evaluation scale for olfaction; Diagnostic Test: Sniffin Stick Test

Study type: Interventional

Funder types: Other

Identifiers

NCT04104594

19CH099

2019-A01625-52 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

patients with chronic rhinosinusitis with nasal polyps

Experimental group

Treatment:

Biological: dosage of 17 cytokines

Other: nasal outcome test

Other: numerical evaluation scale for olfaction

Diagnostic Test: Sniffin Stick Test

Other: numerical evaluation scale for nasal obstruction

Patients with an indication for septoplasty = control group

Other group

Treatment:

Biological: dosage of 17 cytokines

Other: nasal outcome test

Diagnostic Test: Sniffin Stick Test