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.
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
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 group | Role | What they receive |
|---|---|---|
| patients with Nasosinus Polyposis | patients 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.
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.
- First posted24 Sep 2021
- Study start27 Jan 2022
- Primary completion24 Nov 2024
- Study completion24 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PolyposisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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