Delivering Personalised Care in the Management of Exacerbations of Chronic Obstructive Pulmonary Disease: A Multi-centre Randomised Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Proportion of treatment non-responders defined as those needing re-treatment, hospitalisation or death at 30 and 90 days
研究概览
简要总结
To evaluate the efficacy of blood-eosinophil directed corticosteroid therapy using near-patient testing, compared to current standard practice during an exacerbation of COPD in a multi-centre randomised placebo controlled trial.
详细描述
Study design: Double-blind placebo controlled randomised clinical trial Study setting: Primary care GP practices Participants: Adults ≥40 years with COPD Sample size: 228 Study duration: 12 months data collection Primary objective: To evaluate the efficacy of blood-eosinophil directed corticosteroid therapy using near-patient testing, compared to current standard practice during an exacerbation of COPD.
Secondary objective: To evaluate quality of life, symptoms, lung function and healthcare utilisation in a blood-eosinophil directed corticosteroid therapy arm.
Exploratory objective: To evaluate stability of eosinophil counts and mediator levels
Chronic obstructive pulmonary disease (COPD) affects adults and is largely caused by cigarette smoke in the developed world. It is predicted to be the 3rd leading cause of death by 2020 affecting over 250 million people worldwide. COPD is characterised by progressive airflow obstruction punctuated by frequent periods of worsening in respiratory symptoms and function associated with a significant impact on quality of life. These episodes are termed exacerbations and current treatment strategies rely on oral corticosteroids (prednisolone) and antibiotics but this is in a "one size fits all" approach. However there is little evidence supporting this strategy and both treatments can potentially cause harm. In addition to this, previous findings have shown that eosinophil counts within blood samples from COPD patients can be used as a biomarker to determine treatment with oral steroids.
The use of near-patient testing in primary care will characterise patients with COPD and inform to guide effective and personalised treatment with reductions in treatment failure rates, improvements in health and reductions in adverse events associated with inappropriate and excessive corticosteroid and antibiotic therapy. Currently available systems include the HemoCue ® 5-point differential cell count system which accurately and rapidly (within 2 minutes) determine the eosinophil count finger-prick sampling. This diagnostic is currently used in neonatology, Emergency Departments (ED) and at Mount Everest Base Camp 28-30. It is thus conceivable that this could be used in primary care to deliver a randomised control trial to demonstrate that stratified medicine approaches in the management of COPD exacerbations are superior to standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the trial.
- •Male or Female, aged 40 years or above.
- •Diagnosed with COPD (primary or secondary care diagnosis) with spirometric confirmation of airflow obstruction (FEV1/FVC ratio <0.7).
- •A history of at least 1 exacerbation in the previous 12 months, requiring systemic corticosteroids and/or antibiotics.
- •Current or ex-smoker with at least a 10 pack year smoking history
- •In the opinion of the research staff, is able and willing to comply with all trial requirements.
排除标准
- •History of atopic childhood asthma
- •Current history of primary lung malignancy or current active pulmonary TB
- •Clinically relevant disease or disorder (past or present) which in the opinion of the investigator may either put the subject at risk because of participating in the study or may influence the results of the study or the subject's ability to participate in the study.
- •Any clinically relevant lung disease, other than COPD considered by the investigator to be the primary diagnosis. For example mild-to-moderate bronchiectasis is acceptable in addition to COPD unless the bronchiectasis is considered to be the primary diagnosis.
- •An alternative cause for the increase in symptoms of COPD that are unrelated to an exacerbation such as i) suspicion or clinical evidence of pneumonia; ii) high probability and suspicion of pulmonary embolism; iii) suspicion or clinical evidence of a pneumothorax; iv) primary ischaemic event - ST or Non ST elevation myocardial infarct and left ventricular failure [i.e. not an exacerbation of COPD]
- •A known allergy to the IMP (prednisolone), NIMP (doxycycline) or to any of the constituents of the placebo
- •Patients on maintenance corticosteroids (prednisolone, hydrocortisone, fludrocortisone)
- •Known adrenal insufficiency
- •Currently enrolled in another CTIMP trial and receiving an intervention as part of the trial.
- •Pregnant and breast-feeding women
研究组 & 干预措施
Standard care
Blinded prednisolone 30mg orally once per day for 14 days
干预措施: Prednisolone (Drug)
Biomarker care
Blinded prednisolone 30mg orally once per day for 14 days if peripheral eosinophil count is equal or greater than 2%. Placebo equivalent if peripheral blood eosinophil count is <2%.
干预措施: Prednisolone (Drug)
结局指标
主要结局
Proportion of treatment non-responders defined as those needing re-treatment, hospitalisation or death at 30 and 90 days
时间窗: 30 days
Frequency of treatment non-responders, defined as those needing re-treatment, hospitalisation or death
次要结局
- COPD assessment test (CAT)(Day 14, 30 and 90)
- Quality of life - change from baseline(Day 14, 30 and 90)
- Visual analogue scale (VAS) for cough, wheeze, sputum volume, sputum purulence and breathlessness(Day 14, 30 and 90)
- Lung function(Day 14, 30 and 90)
- Exacerbations(12 months)
研究者
Mona Bafadhel
Associate Professor
University of Oxford