Clinical trial NCT04104594: Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps
Official title: Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
Olfaction Disorders
Keywords: TNF alpha
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control and patients
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: expression rate of TNF-alpha in biopsies
timeFrame: 2 months
measure: Sniffin Stick test score
timeFrame: 2 months
Secondary outcomes:
measure: Olfactory Cleft Endoscopic Score
timeFrame: 2 months
measure: expression rate of TNF-alpha in polyps
timeFrame: 2 months
measure: dosage of cytokines G-CSF
timeFrame: 2 months
measure: dosage of cytokines GM-CSF
timeFrame: 2 months
measure: dosage of cytokines IFN-γ
timeFrame: 2 months
measure: 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
timeFrame: 2 months
measure: dosage of cytokines MCP-1
timeFrame: 2 months
measure: dosage of cytokines MIP-1β
timeFrame: 2 months
measure: dosage of cytokines MCAF
timeFrame: 2 months
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU de Saint Etienne
name: Marie GAVID, MD
role: PRINCIPAL_INVESTIGATOR
References: