Development of a Severity Assessment Score for Nasosinus Polyposis (PSI Score)
Key facts
- Who runs it
- Centre Hospitalier Intercommunal Creteil
- Where
- France8 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 569 people enrolled
- Started
- 27 Jan 2022
- Ended
- 24 Nov 2024
- Type of study
- Observational
- Treatments tested
- Questionaries
- Record updated
- 3 February 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- >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
- 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 take part
- 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
- Decline to participate in the study
- No one who speaks or understands French
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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)
The group in the trial
- patients with Nasosinus Polyposis
patients with Nasosinus Polyposis included in the study
Treatment: Questionaries
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 3 February 2025