Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05056714 |
| Other study ID # |
PSI |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 27, 2022 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Centre Hospitalier Intercommunal Creteil |
| Contact |
Emilie BEQUIGNON |
| Phone |
01 49 81 22 25 |
| Email |
Emilie.bequignon[@]chicreteil.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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 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)
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.
