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
- 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
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Severity Assessment Score for Nasosinus Polyposis (PSI Score)
- ClinicalTrials.gov ID
- NCT05056714
- Acronym / sponsor ID
- PSI / PSI
- Conditions
- Nasal Polyposis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 569 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 24 Nov 2024 (actual)
- Study completion
- 24 Nov 2024 (actual)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with Nasosinus Polyposis | – | Other: Questionariespatients with Nasosinus Polyposis included in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with nasosinisal polyposis identified or followed up
Key inclusion criteria (10 listed)
- >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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionariesThe patient will answer several questionaries | Other | patients with Nasosinus Polyposis |
Primary outcome
Develop a severity score for PNS using latent variable modeling: Polyps Severity Index (PSI)
Time frame: 3 months
the estimated value of the structural coefficients relating measurable indicators of PNS to the endogenous latent variable: the severity of the disease (PSI score).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Nasal Polyposis
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Polyposis, run by Centre Hospitalier Intercommunal Creteil at 8 sites 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 10 inclusion and 8 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: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Develop a severity score for PNS using latent variable modeling: Polyps Severity Index (PSI) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2025.