The Ear-Nose-Throat (ENT) Prospective International Cohort of PCD Patients (EPIC-PCD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Ear examination (ear discharge)
研究概览
简要总结
The Ear-Nose-Throat (ENT) Prospective International Cohort of patients with Primary Ciliary Dyskinesia (EPIC-PCD) is a prospective observational clinical cohort study, set up as a multinational multi-centre study. It is embedded into routine patient care of participating reference centres for PCD and patients keep being managed according to local procedures and guidelines.
详细描述
The EPICD-PCD is hosted at the Institute of Social and Preventive Medicine (ISPM) at the University of Bern, Switzerland. Research is performed in close collaboration with all data contributors. This study aims to characterise ENT disease in PCD patients and its association with lower respiratory disease, and to identify determinants of its prognosis.
The investigators aim to:
- Assess the prevalence and severity of sinonasal and otologic symptoms and the frequency and range of signs and physiological findings assessed during standardised ENT physical examination, and describe differences by age;
- Study the association of sinonasal and otologic disease with lower respiratory disease in PCD patients;
- Identify determinants of disease course and prognosis of sinonasal and otologic disease in PCD patients
- Study management practices and identify determinants that inform them.
Study design:
The EPIC-PCD is a prospective observational clinical cohort study, set up as a multinational multi-centre study. It is embedded into routine patient care of participating reference centres for PCD and patients will keep being managed according to local procedures and guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PCD (clinical and test certified)
- •Patient must undergo an ENT examination minimum once a year as part of their clinical follow-up
排除标准
- 未提供
结局指标
主要结局
Ear examination (ear discharge)
时间窗: at baseline
Prevalence of ear discharge at baseline
Sinonasal symptoms and signs
时间窗: at baseline
Prevalence of reported clinical symptoms at different age groups, including rhinitis, sinusitis, snoring
Nasal endoscopy (description of nasal mucosa)
时间窗: at baseline
Description of nasal mucosa as seen via nasal endoscopy examination
Tympanometry
时间窗: at baseline
Results of tympanometry (tympanogram type for both ears) at baseline
Audiometry
时间窗: at baseline
Results of audiometry: type of audiometry and results based on WHO hearing loss grades (for both ears)
Course of otological symptoms and signs (year 1)
时间窗: at 12 months from recruitment
Change from baseline prevalence of reported clinical symptoms at different age groups, including ear pain, hearing problems, ear discharge, at 12 months
Nasal endoscopy (nasal polyps)
时间窗: at baseline
Prevalence of nasal polyps at baseline
Nasal endoscopy (nasal polyps at year 2)
时间窗: at 24 months from recruitment
Changes in prevalence of nasal polyps from baseline to 24 months
Ear examination (ear discharge at year 1)
时间窗: at 12 months from recruitment
Changes in prevalence of ear discharge from baseline to 12 months
Tympanometry (at year 2)
时间窗: at 24 months from recruitment
Changes in tympanogram (for both ears) from baseline to 24 months
Sinonasal examination (Lidholdt score at year 1)
时间窗: at 12 months from recruitment
Changes in Lidholdt score from baseline to 12 months
Nasal endoscopy (nasal polyps at year 1)
时间窗: at 12 months from recruitment
Changes in prevalence of nasal polyps from baseline to 12 months
Sinonasal examination (Lidholdt score at year 2)
时间窗: at 24 months from recruitment
Changes in Lidholdt score from baseline to 24 months
Ear examination (ear discharge at year 2)
时间窗: at 24 months from recruitment
Changes in prevalence of ear discharge from baseline to 24 months
Otoscopy (description of the tympanic membrane at year 2)
时间窗: at 24 months from recruitment
Changes in the tympanic membrane from baseline to 24 months as seen via otoscopy examination
Otological symptoms and signs
时间窗: at baseline
Prevalence of reported clinical symptoms at different age groups, including ear pain, hearing problems, ear discharge
Otoscopy (description of the tympanic membrane)
时间窗: at baseline
Description of tympanic membrane as seen via otoscopy examination
Otoscopy (description of the tympanic membrane at year 1)
时间窗: at 12 months from recruitment
Changes in the tympanic membrane from baseline to 12 months as seen via otoscopy examination
Tympanometry (at year 1)
时间窗: at 12 months from recruitment
Changes in tympanogram (for both ears) from baseline to 12 months
Course of sinonasal symptoms and signs (year 1)
时间窗: at 12 months from recruitment
Change from baseline prevalence of reported clinical symptoms at different age groups, including rhinitis, sinusitis, snoring, at 12 months
Course of sinonasal symptoms and signs (year 2)
时间窗: at 24 months from recruitment
Change from baseline prevalence of reported clinical symptoms at different age groups, including rhinitis, sinusitis, snoring, at 24 months
Course of otological symptoms and signs (year 2)
时间窗: at 24 months from recruitment
Change from baseline prevalence of reported clinical symptoms at different age groups, including ear pain, hearing problems, ear discharge, at 24 months
Nasal endoscopy (changes of nasal mucosa at year 1)
时间窗: at 12 months from recruitment
Changes in nasal mucosa from baseline as seen via nasal endoscopy examination at 12 months
Nasal endoscopy (changes of nasal mucosa at year 2)
时间窗: at 24 months from recruitment
Changes in nasal mucosa from baseline as seen via nasal endoscopy examination at 24 months
Sinonasal examination (Lidholdt score)
时间窗: at baseline
Lidholdt score at baseline
Audiometry (at year 1)
时间窗: at 12 months from recruitment
Changes in audiometry results from baseline to 12 months
Audiometry (at year 2)
时间窗: at 24 months from recruitment
Changes in audiometry results from baseline to 24 months
次要结局
未报告次要终点