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Nasal PolypsOIPNNCT04104594

Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps

A study testing Sniffin Stick Test, numerical evaluation scale for olfaction and numerical evaluation scale for nasal obstruction in people with Nasal Polyps and Chronic Rhinosinusitis With Nasal Polyps, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sniffin Stick Test, numerical evaluation scale for olfaction and numerical evaluation scale for nasal obstruction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteFrance
Study dates
5 Feb 2020to 29 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with nasosinus polyposis requiring nasosinus surgery
  • Patient affiliated or entitled to a social security
  • signed consent
  • Patients with an indication for septoplasty
  • Patient affiliated or entitled to a social security
  • signed consent

Who cannot join

  • 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.
  • Patients with nasosinus polyposis
Show all 11Show fewer
  • 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 locations and contacts

1 site in 1 country.

France1 site

  • Chu Saint-Etienne

    Saint-Etienne

Other trials in France

About this study

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.

Being tested
Sniffin Stick Test, numerical evaluation scale for olfaction, numerical evaluation scale for nasal obstruction, nasal outcome test, dosage of 17 cytokines
Keywords
TNF alpha
Medical subject headings
Nasal Polyps, Olfaction Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sniffin Stick TestDiagnostic 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.

  • numerical evaluation scale for olfactionOther

    numerical rating scale from 0 (no smell) to 10 (perfect smell)

  • numerical evaluation scale for nasal obstructionOther

    numerical rating scale from 0 (no freedom of the nasal passages) to 10 (maximum nasal freedom)

  • nasal outcome testOther

    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

  • dosage of 17 cytokinesBiological

    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

Study groups in NCT04104594
Study groupRoleWhat they receive
patients with chronic rhinosinusitis with nasal polypsExperimentalNot described
Receives: 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
Patients with an indication for septoplasty = control groupOtherNot described
Receives: Diagnostic Test: Sniffin Stick Test; Other: nasal outcome test; Biological: dosage of 17 cytokines

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 months

  2. 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.

    Measured: 2 months

Secondary outcomes (9)

  1. 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

    Measured: 2 months

  2. expression rate of TNF-alpha in polyps

    measured at control and patients.

    Measured: 2 months

  3. dosage of cytokines G-CSF

    measured at control and patients.

    Measured: 2 months

  4. dosage of cytokines GM-CSF

    measured at control and patients.

    Measured: 2 months

  5. dosage of cytokines IFN-γ

    measured at control and patients.

    Measured: 2 months

  6. 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.

    Measured: 2 months

  7. dosage of cytokines MCP-1

    measured at control and patients.

    Measured: 2 months

  8. dosage of cytokines MIP-1β

    measured at control and patients.

    Measured: 2 months

  9. dosage of cytokines MCAF

    measured at control and patients.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2019
  2. Study start5 Feb 2020
  3. Primary completion6 Jul 2021
  4. Study completion29 Jul 2021

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
control and patients
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04104594
Sponsor's protocol ID
19CH099
Other IDs
2019-A01625-52
Acronym
OIPN
Status last verified
Oct 2022
First submitted
24 Sep 2019
Last updated
25 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sniffin Stick Test, numerical evaluation scale for olfaction and numerical evaluation scale for nasal obstruction in people with Nasal Polyps and Chronic Rhinosinusitis With Nasal Polyps, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

expression rate of TNF-alpha in biopsies (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04104594.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.

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