A Phase II, Two-Part, Randomised, Multi-Centre, Multinational, Double-Blind, Placebo-Controlled, Parallel Group Study to Compare the Efficacy and Safety of BCT197 When Added on to Standard of Care for the Treatment of Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease Requiring Hospitalisation in Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Change From Baseline in FEV1 to Day 7 - ITT Population
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of BCT197 when added on to standard of care in adult subjects with acute respiratory exacerbations of chronic obstructive pulmonary disease requiring hospitalization. Additionally, the study will characterize the pharmacokinetics of BCT197 in adults with COPD. The total duration of the study will be 26 weeks. Subjects will receive study treatment administration over a period of 5 days after randomization. It is expected that approximately 255 subjects will complete the study and follow-up.
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
- •Male and female adults
- •Presence of an active exacerbation of the ongoing COPD requiring hospitalization for treatment
- •Subjects with a documented diagnosis of COPD C or D
- •Current smokers or ex-smokers
- •A documented history of at least one moderate or severe COPD exacerbation in the 12 months preceding the Screening Visit that required antibiotics and/or systemic corticosteroid.
- •Current regular treatment for COPD (for at least 2 months prior to the Screening Visit.
排除标准
- •Age less than 40 years old
- •Current diagnosis of asthma
- •Subjects who have already completed treatment for the current exacerbation of COPD
- •Subjects currently requiring intensive care unit (ICU) and/or mechanical ventilation
- •Received a course of PDE4, p38 or PDE3/4 inhibitors within their respective defined washout periods.
研究组 & 干预措施
Regimen 1
Drug: BCT197 Dose 1, Day 1 to Day 5
干预措施: BCT197 (Drug)
Regimen 2
Drug: BCT197 Dose 2, Day 1 to Day 5
干预措施: BCT197 (Drug)
Regimen 3
Placebo Day 1 to Day 5
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in FEV1 to Day 7 - ITT Population
时间窗: Days 1 to 7
FEV1 data were recorded daily from Days 1 to 7 of the study using a computer-operated spirometer. Analysis was based on a linear Mixed Model for Repeated Measures (MMRM) with Change from Baseline in parameter as outcome; including treatment, visit, treatment by visit interaction, severity of airflow limitation at Baseline, blood eosinophils (%) at Baseline, time from start of current chronic obstructive pulmonary disease (COPD) exacerbation to first study treatment dosing, presence of cardiovascular comorbidities at Screening and COPD exacerbation treatment at Screening as fixed effects, and Baseline value and Baseline by visit interaction as covariates. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments. Results were presented with adjusted mean (95% confidence interval).
次要结局
- Time to Improvement of 100 mL in FEV1 Over Time - ITT Population(Baseline to Week 26)
- Change From Baseline in FEV1 on Days 3, 10, and 14 - ITT Population(Days 3, 10, and 14)
- Normalization Evaluation of FEV1 Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population(Baseline, Days 1 to 7, Days 10 and 14, Week 8, Week 12 and Week 26)
- Normalization Evaluation of FEV1/FVC Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population(Baseline to Week 26)
- Time to Improvement Based on the EXAcerbations of Chronic Pulmonary Disease Tool-Patient Reported Outcome (EXACT-PRO) Total Score During the Acute Exacerbation Phase - ITT Population(Days 1 to 29)
- Time From Hospitalization Admission Until the Participant Is Medically Ready for Discharge (Current COPD) - ITT Population(Day 1 to Day 30)
- Area Under the Curve (AUC) of FEV1 Over Time - ITT Population(Day 1 to Day 14)
- Change From Baseline in RR on Days 3, 7, 10 and 14 - ITT Population(Days 1 to 14)
- Time to Recovery Based on EXACT-PRO Total Score During the Acute Exacerbation Phase - ITT Population(Days 1 to 29)
- Percentage of Days With Intake of COPD Rescue Therapy - ITT Population(Baseline to Week 26)
- Normalization of Respiratory Rate (RR) Over Time During Acute Exacerbation Phase - ITT Population(Day 1 to Day 14)
- Standardized AUC of EXACT-PRO Rolling Average Over Time During Acute Exacerbation Phase - ITT Population(Days 1 to 29)
- Standardized AUC of EXACT-PRO (Breathlessness) Rolling Average Over Time During Acute Exacerbation Phase - ITT Population(Days 1 to 29)
- Rate of Positively Adjudicated Moderate/Severe COPD Exacerbations - ITT Population(Day 1 to End of Study (Day 180))
- Number of COPD-Related Deaths During the Study - ITT Population(Days 1 to 180)
- Time to Next Positively Adjudicated Moderate/Severe COPD Exacerbation- ITT Population(Day 1 to Day 180)