Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps

Study Overview
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Brief Summary
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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.

Official Title
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Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps

Conditions
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Nasal Polyps, Chronic Rhinosinusitis With Nasal Polyps, Olfaction Disorders

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: control and patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with chronic rhinosinusitis with nasal polyps<br> | Diagnostic Test: Sniffin Stick Test<br>* 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.<br>Other: numerical evaluation scale for olfaction<br>* numerical rating scale from 0 (no smell) to 10 (perfect smell)<br>Other: numerical evaluation scale for nasal obstruction<br>* numerical rating scale from 0 (no freedom of the nasal passages) to 10 (maximum nasal freedom)<br>Other: nasal outcome test<br>* 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<br>Biological: dosage of 17 cytokines<br>* 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<br>|
| Other: Patients with an indication for septoplasty = control group<br> | Diagnostic Test: Sniffin Stick Test<br>* 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.<br>Other: nasal outcome test<br>* 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<br>Biological: dosage of 17 cytokines<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| expression rate of TNF-alpha in polyps | measured at control and patients. | 2 months | 
| dosage of cytokines G-CSF | measured at control and patients. | 2 months | 
| dosage of cytokines GM-CSF | measured at control and patients. | 2 months | 
| dosage of cytokines IFN-γ | measured at control and patients. | 2 months | 
| 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 | measured at control and patients. | 2 months | 
| dosage of cytokines MCP-1 | measured at control and patients. | 2 months | 
| dosage of cytokines MIP-1β | measured at control and patients. | 2 months | 
| dosage of cytokines MCAF | measured at control and patients. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TNF alpha