Impact Of Eosinophil-Based Corticosteroid Therapy On Treatment Success And Adverse Events In Acute Exacerbation Of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The rate of treatment success in the combination (Eosinophil guided systemic steroid plus high dose inhaled corticosteroid) arm therapy as compared to daily systemic corticosteroid therapy on Day 14
研究概览
简要总结
Although systemic corticosteroids for 5 days is the standard of therapy for AECOPD, recent evidence suggest corticosteroids may be more beneficial in eosinophilic subset of COPD exacerbations, while may cause more harm in non-eosinophilic exacerbations. This study aims to give biomarker-guided therapy based on raised eosinophils and reduce cumulative dose and adverse effects of corticosteroids. The study aims to determine whether eosinophil guided steroid therapy combined with high dose inhaled corticosteroids is comparable to daily systemic corticosteroid therapy in terms of treatment success rates in hospitalised patients with acute exacerbation of COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Clinician diagnosed COPD, and hospitalised due to AECOPD
- •Moderate to severe AECOPD diagnosis as defined by GOLD guidelines 2024, including those requiring HFNC, NIV or IMV
- •Signed informed consent.
排除标准
- •Known diagnosis of bronchial asthma Use of systemic corticosteroids for more than one week in the last 12 weeks More than 36 hours of systemic steroid usage during the current exacerbation Patients fit for discharge within 24 hours of admission or emergency visit Those with contraindications to systemic steroids, or those requiring systemic steroids for alternate indications such as adrenal insufficiency Pregnancy or lactation, severe mental illness Other systemic causes of eosinophilia Recent or current myocardial infarction Active pulmonary tuberculosis Post-tubercular or post-infective obstructive pulmonary disease with extensive scarring sequelae Active malignancy Systemic fungal infections Septic shock Life expectancy of less than 30 days.
结局指标
主要结局
The rate of treatment success in the combination (Eosinophil guided systemic steroid plus high dose inhaled corticosteroid) arm therapy as compared to daily systemic corticosteroid therapy on Day 14
时间窗: Day 14
次要结局
- Composite of adverse outcomes (Mortality , Prolonged hospital/ICU stay, ,COPD re-exacerbation leading to ER visits, re-admittance to hospital(Day 14 and 28)
- Length of ICU and hospital stay(Day of Transfer out of ICU)
- All-cause mortality rate(Day 28 and Day 90)
- Cumulative corticosteroid dosage(baseline, Day 14, and Day 28)
研究者
Dr Kartikeya Kumar Sharma
All India Institute of Medical Sciences