2023-508068-31-00招募中4 期
Dupilumab treatment in patients with chronic rhinosinusitis with nasal polyps: the effect on comorbid eosinophilic otitis media
Amsterdam UMC1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年8月19日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of questionnaire scores between baseline and 6 or 12 months of treatment in CRSwNP+EOM patients
研究概览
简要总结
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
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
次要结局
- 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
研究者
Sietze Reitsma
Scientific
Amsterdam UMC
研究点 (1)
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