Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Physical activity
研究概览
简要总结
Respiratory disease affects one in five people and is a leading cause of global morbidity and mortality. Chronic obstructive airways diseases encompass conditions characterised by expiratory airflow limitation, exertional dyspnoea, activity limitation and impaired quality of life. The most common conditions include chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, cystic fibrosis and primary ciliary dyskinesia. In recent years, there has been concerted effort in the scientific and respiratory medicine community to improve the diagnosis and management of chronic obstructive airways diseases using personalised or precision medicine (i.e., tailoring therapies and interventions according to specific "treatable traits") and identifying phenotypes or endotypes using validated biomarkers. To date, however, research in this setting has primarily focussed on people with COPD and asthma, with limited studies in other forms of chronic obstructive airways diseases. The aim of this study is therefore two-fold; first, to compare pulmonary physiology (i.e., large and small airway involvement) and extra-pulmonary manifestations across the spectrum of chronic obstructive airways, and second, to determine how disease-specific treatable traits associate with physical activity and health-related quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Prior diagnosis of airways disease in accordance with European Respiratory Society guidelines.
- •Non / ex-smokers (packs recorded as cigarettes per day / years smoked).
- •Male or female aged 18-65 years
- •Ability to provide written informed consent.
- •Full comprehension of spoken and written English language.
- •Cystic Fibrosis patients on triple CFTR modulators (90% cohort)
- •Cystic Fibrosis patients on no CFTR modulators
- •Healthy controls - entirely asymptomatic, no prior history of inhaler medication use and free from respiratory disease.
排除标准
- •Severe exacerbation requiring hospital admission or oral corticosteroids (OCS) in the past two months.
- •Absolute or relative contraindications to cardio-pulmonary exercise testing or submaximal exercise testing.
- •Absolute or relative contraindications to pulmonary function testing .
- •Absolute or relative contraindications to dual energy x-ray (DEXA) scanning (i.e., pregnancy, recent contrast media administration or subject weight).
- •Non-ambulant or musculoskeletal impairment that may affect activities of daily living or maximal exercise testing.
- •Significant cognitive impairment (i.e., unable to provide written informed consent or safely / successfully perform tests).
- •Currently receiving oxygen therapy.
- •Inability to consent.
- •Burkholderia Cepacia Complex, mycobacterium tuberculosis or mycobacterium abseccus infection.
- •Lung transplantation
- •Diagnosis of cardiovascular disease.
- •Abnormal blood screening (anaemia, moderate / severe renal failure etc.)
结局指标
主要结局
Physical activity
时间窗: 7 day period
Step-count
次要结局
未报告次要终点
研究者
Dr Oliver Price
Principal Investigator
University of Leeds
