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

NCT06017427 | Terminated

• 1 other identifier: 22-005
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Rhinosinusitis With Nasal Polyps

Keywords

CRSwNP; decreased quality of life; Nasal polyps; Rhinosinusitis; recurrent CRSwNP; severe CRSwNP

Outcome Measures

Primary Outcomes (3)

• Assessment of the global effect of Dupilumab 1 day before Dupilumab by the mean of the SNOT 22 score

  The SNOT22 score is a validated questionnaire for the assessment of symptoms of Chronic rhinosinusitis, ranging from 0 to 110. The more severe are the disease and its associated symptoms, the higher is the score

  1 day before Dupilumab

• Assessment of the global effect of Dupilumab 6 months of Dupilumab treatment by the mean of the SNOT 22 score

  The SNOT22 score is a validated questionnaire for the assessment of symptoms of Chronic rhinosinusitis, ranging from 0 to 110. The more severe are the disease and its associated symptoms, the higher is the score

  6 months of Dupilumab treatment

• Assessment of the global effect of Dupilumab 6 months after stopping the treatment by the mean of the SNOT 22 score

  The SNOT22 score is a validated questionnaire for the assessment of symptoms of Chronic rhinosinusitis, ranging from 0 to 110. The more severe are the disease and its associated symptoms, the higher is the score

  6 months after stopping Dupilumab treatment

Secondary Outcomes (12)

• Assessment of the effect of Dupilumab on nasal obstruction by the mean of the Visual Analogic Scale for nasal obstruction

  1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment

• Assessment of the effect of Dupilumab on the olfaction by the mean of the Visual Analogic Scale for Olfaction

  1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment

• Assessment of the effect of Dupilumab on the severity of the nasal polyposis by the mean of the Nasal Polyp Score

  1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment

• Assessment of the effect of Dupilumab on the severity of the nasal polyposis on an iconographic level by the mean of the Lund McKay score

  1 day before the treatment initiation

• Assessment of the effect of Dupilumab on the quality of life by the mean of the EQ 5D 5L score

  1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment

Study Arms (1)

Patients suffering from severe recurrent CRSwNP and treated with Dupilumab

Patients suffering from severe recurrent CRSwNP despite having benefited from the appropriate medical and surgical treatment and treated with Dupilumab for 6 months

Other: Questionnaires

Interventions

Questionnaires OTHER

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

Patients suffering from severe recurrent CRSwNP and treated with Dupilumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients, men or women, of any age, having received treatment with Dupilumab for the indication of recurrent severe nasal polyposis despite surgery and appropriate medical treatment

You may qualify if:

• Women and men over 18 years old
• Suffering from severe and recurrent Chronic Rhinosinusitis with Nasal Polyps despite having benefited from the appropriate medical and surgical treatment.
• CRSwNP diagnosis established on the basis of clinical presentation and patient interrogation by their referent ENT surgeon.
• Patient treated with Dupilumab in the indication depicted in bullet point 2.
• Patient having voiced their non-opposition to this research, having received clear and appropriate information.
• Patient affiliated to the French Social Security.

You may not qualify if:

• Patient having undergone endoscopic nasal surgery during their Dupilumab treatment.
• Patient suffering from immune deficit.
• Patient suffering from vascularitis with nasal expression.
• Patient whose autonomy has been reduced by a legal authority.
• Patient unable to express their agreement to participate in this study.

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Hautepierre Hospital

Strasbourg, 67000, France

Location

Related Publications (16)

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MeSH Terms

Conditions

Nasal Polyps; Rhinosinusitis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Léa FATH, MD, PhD

  HUS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 30, 2023
• Study Start: August 30, 2023
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)