DUPILUMAB for Chronic rhinosinusitis with nasal polyps | Eosinophilic otitis media

Inclusion criteria

• {"criterion_text":"- Retrospective part: - CRSwNP+EOM patients having started dupilumab treatment from 2020 onwards with sufficient data to meet the primary endpoint (otologic questionnaires [OQUA and DCES] at baseline and at least at 6 or 12 months of treatment)"}
• {"criterion_text":"- Prospective part: adult (18 years and above) CRSwNP+EOM patients starting dupilumab treatment as part of regular clinical care"}

Exclusion criteria

• {"criterion_text":"- Prospective part: not being capable of filling in study questionnaires"}
• {"criterion_text":"- Prospective part: not being able to undergo audiometry"}
• {"criterion_text":"- Prospective part: <18 years of age"}
• {"criterion_text":"- Retrospective part: no consent to use the clinical data"}

Primary endpoints

• {"endpoint_text":"- Change of questionnaire scores between baseline and 6 or 12 months of treatment in CRSwNP+EOM patients","definition_or_measurement_approach":"Change in otologic questionnaire scores between baseline and 6 or 12 months of treatment; otologic questionnaires referenced in protocol/inclusion criteria include OQUA and DCES."}

Secondary endpoints

• {"endpoint_text":"- Change of audiometry outcomes between baseline and 6 or 12 months of treatment","definition_or_measurement_approach":"Change in audiometry outcomes measured by audiometric testing between baseline and 6 or 12 months."}
• {"endpoint_text":"- Change of questionnaire scores between baseline and 1, 3, 6 and 12 months of treatment","definition_or_measurement_approach":"Change in questionnaire scores (patient-reported) measured at baseline and at 1, 3, 6 and 12 months."}
• {"endpoint_text":"- Change of otoscopic findings between baseline and 1, 3, 6 and 12 months of treatment","definition_or_measurement_approach":"Change in otoscopic examination findings recorded at baseline and at 1, 3, 6 and 12 months."}

Methods

• Patients already regularly treated with dupilumab are asked to participate; recruitment occurs within clinical care at participating site(s) (Amsterdam UMC) in the Netherlands. The decision to use the medication is made prior to trial participation and only those already on treatment are approached.

Netherlands

Earliest CTIS Part Ii Submission Date

01-08-2024

Latest Decision Or Authorization Date

19-08-2024

Processing Time Days

18

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Sanofi","duties_or_roles":"Monetary support","organisation_type":"Pharmaceutical company"}