The Effect of Reduced Corticosteroid Therapy in Patients With Acute Exacerbation of COPD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 318
- 试验地点
- 4
- 主要终点
- Days alive and out of hospital within 14 days after recruitment
研究概览
简要总结
This study explores whether patients hospitalized with chronic obstructive pulmonary disease (COPD) exacerbation may have fewer days with prednisolone and with the same treatment effect by controlling the treatment by daily measurements of eosinophils.
详细描述
The most commonly used treatment for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is a 5-day treatment with corticosteroids in moderate-high dose. Some patients receive repeated treatments, although it has been shown that corticosteroids only have temporary beneficial effects and no effect in relation to serious incidents or mortality. It has been found that the higher accumulated prednisolone dose disables patients due to serious side effects, including pneumonia, dysregulated diabetes, bone fracture in the context of osteoporosis, mental disorder and adrenal insufficiency etc. However, the extent of the side effects is unknown. Recent research has shown that it is presumably only a small subset of COPD patients who benefit from corticosteroid therapy. This group can be identified by the biomarker "blood-eosinophils" as already measured on most AECOPD patients during hospitalization.
This is a randomized, controlled, multi-center, non-Inferiority trial evaluating the effect of eosinophil guided corticosteroid therapy to patients with AECOPD. The aim of the study is to investigate whether the accumulated dose corticosteroid treatment during admissions for AECOPD can be reduced, including the presumed side effects, while (still) remaining the optimal treatment effect.
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
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Blood eosinophil guided prednisolone treatment
Intravenous Solu-Medrol 80 mg, followed by prednisolone tablet 37.5 mg daily (maximum of 5 days in all) if the eosinophil count in the blood ≥ 0.3 x 10E9/L. Eosinophil count in the blood <0.3 x 10E9/L results in no treatment with prednisolone. If the patient is discharged during the treatment period, given treatment from the last measured eosinophil count the remaining days.
干预措施: Prednisolone (Drug)
Standard of care
Intravenous Solu-Medrol 80 mg on the first day followed by 37.5 mg of prednisolone tablets (1 x 25 mg plus 1 x 12.5 mg) daily for 5 days
干预措施: Prednisolone (Drug)
结局指标
主要结局
Days alive and out of hospital within 14 days after recruitment
时间窗: 14 days from recruitment
次要结局
- Treatment failure (Recurrence of AECOPD resulting in emergency room visits, hospitalization or need to intensify pharmacological treatment within 30 days)(30 days)
- Change in lung function (ΔFEV1) on day 3, after 1 month and 3 month(90 days)
- Mortality(360 days)
- Cumulative corticosteroid dose at 1 and 3 month follow-up(90 days)
- Changes in PTH and Vitamin D status between hospitalization and 3-month follow-up(90 days)
- Infection requiring antibiotic treatment within 180 days after the index of AECOPD(180 days)
- The period between index AECOPD and the next AECOPD exacerbation(90 days)
- Hyperglycemia during admission(14 days)
- Change in bone marker levels (Serum P1NP, Serum CTX)(90 days)
- New onset or worsening of diabetes mellitus(30 days)
- Increase in body mass index between hospitalization, at 30 days and 3-month follow-up(90 days)
- The impact of COPD (cough, sputum, dysnea, chest tightsenes etc) on health status (COPD Assessment Test) between hospitalization, at 30 days and 3-month follow-up(90 days)
- Changes in level of dyspnea using the Medical Research Council (MRC) Dyspnoea Scale between hospitalization, at 30 days and 3-month follow-up(90 days)
- Osteoporotic fractures(360 days)
- Dyspepsia or ulcer complications (gastrointestinal bleeding)(90 days)
研究者
Pradeesh Sivapalan
MD, Ph.d.-student
Chronic Obstructive Pulmonary Disease Trial Network, Denmark