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Nasal PolyposisPSINCT05056714

Development of a Severity Assessment Score for Nasosinus Polyposis (PSI Score)

An observational study of Nasal Polyposis, run by Centre Hospitalier Intercommunal Creteil at 8 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

nasosinus polyposis (=PNS) is a chronic inflammatory disease of the nasal cavity and sinus cavity with a prevalence of 2 to 4% in the general population. The functional impact of PNS has a major impact on one's quality of life.Medical treatment, nasal irrigations and local glucocorticoids as well as short treatment of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nasal Polyposis
What is being tested?
Questionaries
How many people
569 participants
Where
8 sitesFrance
Study dates
27 Jan 2022to 24 Nov 2024
How long will I take part?
3 Months
Phase
Observational

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

Study population: Patients with nasosinisal polyposis identified or followed up

Who may be able to join

  • >18 years
  • Patients included are all adult (>18 years) patients with PNS: Inflammation of the nose and sinuses that is characterised by two or more of the following symptoms (at least one of which must be nasal obstruction or runny nose):
  • Nasal obstruction and nasal congestion
  • Rhinorrhoea (anterior or posterior)
  • Facial pain or pressure
  • Decreased or loss of sense of smell
Show all 10Show fewer
  • Sneezing and/or nasal pruritus
  • These symptoms should be associated with :
  • Endoscopic signs of nasal polyps
  • Diffuse bilateral naso-sinusal opacities on CT or CBCT

Who cannot join

  • Decline to participate in the study
  • No one who speaks or understands French
  • History of skull base surgery for tumours
  • History of major head trauma
  • History of cerebral-facial radiotherapy or chemotherapy
  • History of inflammatory or neurodegenerative neurological pathology
  • Systemic disease associated with the presence of sinus polyps (Granulomatosis - with polyangiitis, cystic fibrosis, primary ciliary dyskinesia, immune deficiency)
  • Cancer or haematological disease in progress

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites
  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94000

  • Hôpital Henri Mondor

    Créteil, 94010

  • Hôpital kremlin Bicêtre

    Le Kremlin-Bicêtre, 94270

  • CHU Liile

    Lille, 59000

  • Hôpital de la Croix Rousse

    Lyon, 69004

  • CHU Lyon Sud

    Lyon, 69310

  • Hôpitaux Universitaires de Marseille Conception

    Marseille, 13005

  • Hôpital Lariboisiere

    Paris, 75010

Other trials in France

About this study

nasosinus polyposis (=PNS) is a chronic inflammatory disease of the nasal cavity and sinus cavity with a prevalence of 2 to 4% in the general population. The functional impact of PNS has a major impact on one's quality of life.Medical treatment, nasal irrigations and local glucocorticoids as well as short treatment of oral glucocorticoids have shown a short-term benefit versus placebo. Surgery improves the efficacy of local treatments, but 40% of patients have a recurrence of polyps at 18 months and 20% of patients require a surgery recovery at 5 years. The development of monoclonal antibodies directly targeting the inflammatory way is a real public health issue. Bachert C. et al recently demonstrated the efficacy of Dupilumab (anti-IL-4/13 antibody) injected subcutaneously on the overall symptomatology of PNS. The marketing authorization (AMM) for the first biotherapy to be available soon includes PNS's severe nature and resistance to treatment, although there is no consensus definition or score to characterize this severity. This study aims at developping a score for assessing severity in PNS. We suggest that this assessment strategy could be applied to the PNS. The originality and the innovative character of this project is the statistical modeling behind the creation of the score. Thus, the importance of symptoms, anatomical and biological factors, the estimation of the quality of life of the patients, the level of care use and the number of surgeries all become measurable indicators that are a direct reflexion of the severity and the control of PNS, called latent variables because they cannot be directly measured. To consider this detail, modeling using structural equations seems optimal to develop a severity score (PSI score) of PNS in order to personalize the therapeutic care of patients. Main Objective: To develop a severity score for PNS using latent variable modeling: Polyps Severity Index (PSI)

Read the detailed description

In practice, during their otolaryngologist (ORL) consultation, patients will have a complete clinical check-up and will be prescribed the necessary complementary examinations if they have not already been performed recently (<6 months). All data will be collected in an anonymous database.

The patient will answer a questionnaire to evaluate the cardinal symptoms of PNS using a visual scale from 0 to 10. He will then have a standard ORL clinical check-up (otoscopy, then rhinoscopy with speculum and nasal endoscopy) in order to make a nasal anatomical assessment (duration 5 minutes).

They will be given a questionnaire on admission to the waiting room to find out the impact of their nasal discomfort on their quality of life (score used routinely and validated in the literature, SNOT-22), as well as a questionnaire concerning their asthma if it exists (score used routinely and validated in the literature, ACT). The importance of the endoscopic involvement will be evaluated using the Lidholt score (see Appendix) and the importance of the radiological involvement directly from the CT or Cone beam computed tomography (=CBCT) results using the Lund-MacKay score. The estimated time to complete these questionnaires and to assess the endoscopic and radiological involvement is an additional 10 minutes. Blood will be drawn (as part of the initial routine workup) to assess complete blood count (for blood hypereosinophilia) and IgE levels (serum and total IgE). We will repeat the assessment routinely performed as part of the follow-up of patients with PNS by questionnaire, interview and physical check-up at 3 months when the patients return for their follow-up visit. No additional exams or questionnaires to the routine workup will be performed for this study.

Conditions
Nasal Polyposis
Being tested
Questionaries
Medical subject headings
Nasal Polyps

What participants receive

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

  • QuestionariesOther

    The patient will answer several questionaries

Study groups in NCT05056714
Study groupRoleWhat they receive
patients with Nasosinus Polyposispatients with Nasosinus Polyposis included in the study
Receives: Other: Questionaries

What is being measured

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

  1. Develop a severity score for PNS using latent variable modeling: Polyps Severity Index (PSI)

    the estimated value of the structural coefficients relating measurable indicators of PNS to the endogenous latent variable: the severity of the disease (PSI score).

    Measured: 3 months

Timeline

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

  1. First posted24 Sep 2021
  2. Study start27 Jan 2022
  3. Primary completion24 Nov 2024
  4. Study completion24 Nov 2024

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
569 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05056714
Sponsor's protocol ID
PSI
Acronym
PSI
Status last verified
Feb 2023
First submitted
16 Sep 2021
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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