2023-508068-31-00
Recruiting
Phase 4
Dupilumab treatment in patients with chronic rhinosinusitis with nasal polyps: the effect on comorbid eosinophilic otitis media
Amsterdam UMC1 site in 1 country50 target enrollmentStarted: August 19, 2024Last updated:
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Amsterdam UMC
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change of questionnaire scores between baseline and 6 or 12 months of treatment in CRSwNP+EOM patients
Overview
Brief Summary
This study aims to determine the effect of dupilumab on ear symptoms and auditory function in chronic rhinosinusitis with nasal polyp and eosinophilic otitis media patients
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
- •Prospective part: adult (18 years and above) CRSwNP+EOM patients starting dupilumab treatment as part of regular clinical care
Exclusion Criteria
- •Prospective part: not being capable of filling in study questionnaires
- •Prospective part: not being able to undergo audiometry
- •Prospective part: <18 years of age
- •Retrospective part: no consent to use the clinical data
Outcomes
Primary Outcomes
Change of questionnaire scores between baseline and 6 or 12 months of treatment in CRSwNP+EOM patients
Change of questionnaire scores between baseline and 6 or 12 months of treatment in CRSwNP+EOM patients
Secondary Outcomes
- Change of audiometry outcomes between baseline and 6 or 12 months of treatment
- Change of questionnaire scores between baseline and 1, 3, 6 and 12 months of treatment
- Change of otoscopic findings between baseline and 1, 3, 6 and 12 months of treatment
Investigators
Sietze Reitsma
Scientific
Amsterdam UMC
Study Sites (1)
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