Evaluation of Nasal Biomarkers for Objective Assessment of Disease Severity in Respiratory Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Nasal biomarker discovery
研究概览
简要总结
This research study is an observational, single site study quantifying expression of biomarkers of respiratory disease in nasal fluid using the ABEL microsampler device. The primary objective of this study is to compare biomarker expression between healthy controls and participants with respiratory disorders such as chronic obstructive pulmonary disorder (COPD), hayfever, chronic sinusitis, asthma and rhinitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants:
- •18 years of age or older
- •The participant must be able to comprehend and sign an approved Informed Consent Form and other applicable study documents.
- •Healthy volunteers:
- •No significant sinonasal/pulmonary symptoms or prior diagnoses of sinonasal/pulmonary conditions as determined by pre-enrolment questionnaires.
- •Case goup:
- •Participants must be previously diagnosed with rhinitis, chronic sinusitis, asthma, or COPD by a medical professional.
排除标准
- •Less than 18 years of age at the time of enrolment.
- •Volunteers who are actively pregnant
- •Prior history of adverse reaction or contraindicated to diagnostic testing including fingerprick blood sampling, pulmonary testing, nasal swab/sampling.
- •Any other conditions limiting the volunteer's ability to complete study requirements in the judgement of the investigator/clinician
- •Any nasal anatomical issue or finding which may limit the safe insertion of the ABEL collection device, as determined by investigator/clinician
- •History of nasal surgery or trauma within the last 3 months
研究组 & 干预措施
Chronic sinusitis sufferers
Previously diagnosed chronic sinusitis sufferers with/without nasal polyps.
干预措施: ABEL microsampler device (Device)
Healthy Controls
Healthy volunteers.
干预措施: ABEL microsampler device (Device)
COPD sufferers
Previously diagnosed COPD sufferers.
干预措施: ABEL microsampler device (Device)
Asthma sufferers
Previously diagnosed asthma sufferers of various subtypes.
干预措施: ABEL microsampler device (Device)
Allergic rhinitis sufferers
Previously diagnosed seasonal or perennial allergic rhinitis sufferers.
干预措施: ABEL microsampler device (Device)
结局指标
主要结局
Nasal biomarker discovery
时间窗: From participant enrollment to the end of the site visit (up to a maximum of 26 weeks)
To establish a correlation between nasal molecular biomarkers and disease severity and quality of life in patients with respiratory conditions (rhinitis, chronic sinusitis, asthma, COPD) compared to healthy controls, aiming to develop an objective biomarker-based disease severity score.
次要结局
- ABEL microsampler validation(For the duration of nasal fluid sample collection at the study site visit (2 hour site visit, with up to 20 minutes allocated for nasal fluid collection with breaks).)