Efficacy and Safety of Oral Corticosteroids for the Treatment of Acute Exacerbations of COPD in General Practice
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Treatment failure
研究概览
简要总结
Primary objective:
The aim of this study is to determine the efficacy and safety of five days of oral corticosteroids (40 mg / day) for the treatment of acute exacerbations of COPD (AECOPD) in outpatients.
详细描述
COPD is a major and growing public health issue. The vast majority of cases are cared for in primary care, both for follow-up in stable state and for treatment of exacerbations, which represent major events in the natural history of the disease.
Systemic corticosteroid treatment is often proposed for exacerbations treatment, although guidelines in this area are heterogeneous regarding precise indications of this treatment. The latest data from the literature, seems to show efficacy of oral corticosteroids but involved only patients seen at the hospital. General practitioners need evidence-base informations to choose whether or not they have to give oral corticosteroids to their patients ; therefore it is very important to better define the benefit-risk ratio and precise indications of oral corticosteroids as part of the care for COPD exacerbations.
The investigators built a randomized double-blind controlled trial to answer this question.
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
- Double (Participant, Investigator)
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
- •Adults aged 40 years and over
- •Smoking ≥ 10 pack-years
- •Patients with suspected acute exacerbation of COPD
- •Patients who gave their written informed consent to participate in the study
排除标准
- •Known or suspected chronic respiratory disease other than COPD (asthma, bronchiectasis ...)
- •Suspected pneumonia or pulmonary oedema
- •Decision of hospitalization
- •Patients taking oral corticosteroids running or stopped for less than a week before inclusion
- •Pathology compromising compliance
- •Fever unexplained by the current AECOPD
- •Uncontrolled hypertension
- •Uncontrolled diabetes
- •Deep infectious disease
- •History of ancient untreated tuberculosis
- •Untreated peptic ulcer
- •Unhealed wound
- •Ulcerative Colitis
- •Allergy to steroids
- •Any severe or uncontrolled infections who are not specified as therapeutic indication in the SPC (Summary of Product Characteristics)
- •Hepatitis, acute genital herpes, varicella, acute zoster
- •Live attenuated vaccine, recent or planned
- •Psychoses not controlled by treatment
- •Hypersensitivity to prednisone or any of the excipients of Cortancyl®, including lactose intolerance
- •Patients who have already been included in BECOMEG
- •Patients who have to move within 8 weeks after inclusion in the study
- •Patients who are not affiliated to the national health insurance
研究组 & 干预措施
Prednisone
干预措施: Prednisone (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment failure
时间窗: 8 weeks
Occurrence of one of the following events within 8 weeks after inclusion: * emergency visit (s) or consultation (s) (use of unscheduled care) related or not to the respiratory status of the patient * visit (s) to the emergency department, related or not to respiratory status * hospitalization (s), related or not to respiratory status * death, related or not to the respiratory status
次要结局
- MYMOP (Measure Yourself Medical Outcome Profile)(8 weeks)
- Dyspnea Medical Research Council (MRC) score(8 weeks)
- Occurrence of each event(8 weeks)
- Treatment Failure related to respiratory status(8 weeks)
- Self-managed relapse or recurrence(8 weeks)
- COPD Assessment Test (CAT)(8 weeks)
- Adverse events(8 weeks)
- Quality of life-adjusted survival (Q-TWIST)(8 weeks)