MedTrace Logo

Evaluation of Patient Satisfaction During Treatment With Dupilumab in Severe and Recurrent Nasosinusal Polyposis Despite Appropriate Medical and Surgical Treatment.

NCT06017427 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2024-01-08

No results posted yet for this study

Summary

Chronic rhinosinusitis with nasal polyps (CRSwNP) or nasal polyposis is a frequent disease leading to a decreased quality of life. The validated course of treatment is firstly a medical one with saline irrigations and topical corticosteroids, followed by surgery (ethmoidectomy) if the medical treatment fails.

In many cases, CRSwNP becomes a recurrent disease despite maximal treatment as previously indicated and it becomes refractory, with a chronically reduced quality of life.

New treatments known as Biologics or Biotherapies in France such as Dupilumab are now available in situations of severe recurrent CRSwNP despite the appropriate treatment.

The goal of this study is to assess the clinical effectiveness of Dupilumab and patient satisfaction, in a cohort of french patients, focusing on the change in quality of life that is expected from said treatment, over a period of one year.

Patients will undergo 6 months of treatment with Dupilumab, the treatment will then be stopped for the next 6 months.

The primary judgment criteria will be the SNOT 22 score, measured before treatment, after 6 months of treatment, and 6 months after stopping treatment, over a telephonic conversation.

Conditions

Interventions

OTHER

Questionnaires

Submission of several questionnaires (Quality of Life and clinical scores) at three time points: before initiation of Dupilumab, after 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment

Sponsors & Collaborators

  • IHU Strasbourg

    lead OTHER

Principal Investigators

  • Léa FATH, MD, PhD · HUS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-30
Primary Completion
2023-09-21
Completion
2023-09-21

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06017427 on ClinicalTrials.gov