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

Primary Purpose

Nasal Polyps, Chronic Rhinosinusitis With Nasal Polyps, Olfaction Disorders

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sniffin Stick Test
numerical evaluation scale for olfaction
numerical evaluation scale for nasal obstruction
nasal outcome test
dosage of 17 cytokines
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nasal Polyps focused on measuring TNF alpha

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chu Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

patients with chronic rhinosinusitis with nasal polyps

Patients with an indication for septoplasty = control group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
expression rate of TNF-alpha in polyps
measured at control and patients.
dosage of cytokines G-CSF
measured at control and patients.
dosage of cytokines GM-CSF
measured at control and patients.
dosage of cytokines IFN-γ
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
measured at control and patients.
dosage of cytokines MCP-1
measured at control and patients.
dosage of cytokines MIP-1β
measured at control and patients.
dosage of cytokines MCAF
measured at control and patients.

Full Information

First Posted
September 24, 2019
Last Updated
October 21, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT04104594
Brief Title
Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps
Acronym
OIPN
Official Title
Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
The laboratory in which the analyses on nasosinusal polyposis were to be carried out did not want to continue the research on this subject, so it was decided to stop this study prematurely.
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
July 6, 2021 (Actual)
Study Completion Date
July 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Polyps, Chronic Rhinosinusitis With Nasal Polyps, Olfaction Disorders
Keywords
TNF alpha

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
control and patients
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with chronic rhinosinusitis with nasal polyps
Arm Type
Experimental
Arm Title
Patients with an indication for septoplasty = control group
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Sniffin Stick Test
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
numerical evaluation scale for olfaction
Intervention Description
numerical rating scale from 0 (no smell) to 10 (perfect smell)
Intervention Type
Other
Intervention Name(s)
numerical evaluation scale for nasal obstruction
Intervention Description
numerical rating scale from 0 (no freedom of the nasal passages) to 10 (maximum nasal freedom)
Intervention Type
Other
Intervention Name(s)
nasal outcome test
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
dosage of 17 cytokines
Intervention Description
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
Primary Outcome Measure Information:
Title
expression rate of TNF-alpha in biopsies
Description
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.
Time Frame
2 months
Title
Sniffin Stick test score
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Olfactory Cleft Endoscopic Score
Description
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
Time Frame
2 months
Title
expression rate of TNF-alpha in polyps
Description
measured at control and patients.
Time Frame
2 months
Title
dosage of cytokines G-CSF
Description
measured at control and patients.
Time Frame
2 months
Title
dosage of cytokines GM-CSF
Description
measured at control and patients.
Time Frame
2 months
Title
dosage of cytokines IFN-γ
Description
measured at control and patients.
Time Frame
2 months
Title
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
Description
measured at control and patients.
Time Frame
2 months
Title
dosage of cytokines MCP-1
Description
measured at control and patients.
Time Frame
2 months
Title
dosage of cytokines MIP-1β
Description
measured at control and patients.
Time Frame
2 months
Title
dosage of cytokines MCAF
Description
measured at control and patients.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie GAVID, MD
Organizational Affiliation
CHU de Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
Saint-Étienne
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps

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