Exploring and comparing the effectiveness of initial Pharmacotherapy (ICS+LABA Vs LABA+LAMA) on Lung Outcomes in biomass–smoke-exposed COPD subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 4
- 主要终点
- 1 Mean change in trough FEV1
研究概览
简要总结
The study will include 260 biomass-exposed male and female COPD patients aged 35 years and above defined by GOLD 2023 criteria as symptoms + risk factors + post-bronchodilator FEV1 by FVC less than 0.70 and FEV1 less than 80 percent These participants will be enrolled from 10 centers across India and must be either treatment naïve or previously diagnosed COPD patients A 4-week washout or run-in period with plus 3 days if needed will be required for those previously on treatment
Baseline assessments will include spirometry chest X ray if done in last 6 months hemogram and where available oscillometry and FeNO Subjects will be grouped based on eosinophil counts those with 300 cells per mm3 or more n is130 and those with less than 300 cells per mm3 n is 130 In each group 65 will be randomly assigned to receive LABA and ICS and 65 to LABA and LAMA. Screening will account for a 20 percent dropout rate
After randomization participants will be followed up at weeks 4 12 and 24 with a 4 day flexibility window Asthalin will be used as rescue medication if needed During the run in or washout period subjects will receive Ipratropium and Levosalbutamol up to 4 times daily exceeding this will lead to withdrawal Medication will be stopped 24 hours before baseline recruitment and eosinophil testing Completion of the washout will be verified by the site investigator
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 99.00 Year(s)（—）
入选标准
- •1 Age more than equal to 35 years 2 Gender Female and Male 3 Exposure to biomass fuel like wood Animal dung crop residues The Biomass Exposure Index BEI should be more than equal to 60 This index is calculated as the average hours spent on cooking per day multiplied by the number of years of cooking Accordingly patients can be recruited if they have a history of exposure such as 2 hours per day for 30 years 3 hours per day for 20 years or 4 hours per day for 15 years or any other exposure duration leading to a BEI of more than equal to 60 4 Symptoms Either one of the symptoms should be present Cough Shortness of breath Wheeze Chest tightness 5 Spirometry Post BD FEV1 by FVC more than 70 percentage and FEV1 percentage pred more than 80 percentage but less than 30 percentage.
- •Spirometry will be conducted at screening for the naïve subjects and previously diagnosed cases of COPD Spirometry tests to be scheduled basis the time of the last inhaler taken in advance of the date of the test with appropriate instructions given to the patient for withholding the next dose and the time at which they need to report for the test.
排除标准
- •1 Subjects unwilling to sign the informed consent 2 Subjects unwilling to come for the follow up visits 3 BEI of less than 60 4 Subjects with a current diagnosis of Asthma or Bronchiectasis 5 Any form of tobacco smoking that is Bidis cigarettes hookahs chillum etc 6 History of Pulmonary TB treated and cured in the past 7 Subjects on current oral corticosteroids 8 Hypersensitivity to glycopyrronium or formoterol or budesonide or levosalbutamol or any of its components 9 Subjects with any hospitalization required for severe exacerbation or any serious condition within past 12 weeks from screening 10 Subjects requiring oral/parenteral corticosteroids within past 4 weeks from screening 11 Subjects requiring oxygen therapy at least 12 hours daily in past 4 weeks from screening 12 Clinically significant ECG abnormality 13 Clinically significant neurologic cardiovascular hepatic renal endocrine pulmonary post tuberculosis fibrosis pulmonary fibrotic disease pulmonary arterial hypertension hematologic psychiatric or other medical illness that will interfere with participation in this study 14 History of asthma present or past rule out complete history and examination of asthma and/or post bronchodilator FEV1 values greater than 400ml of predicted normal values with persistent airflow limitation or history of atopy or any other chronic respiratory disease other than COPD 15 Life threatening unstable respiratory disease including lower respiratory tract infection, within past 4 weeks from screening 16 History of lung resection of more than one full lobe 17 Scheduled for in patient hospitalization including elective surgery during the trial 18 History of clinically significant bladder neck obstruction or urinary retention 19 History of glaucoma 20 History of uncontrolled diabetes mellitus 21 Participation in clinical trial in within past 4 weeks of screening.
- •22 Female who is pregnant or lactating or planning to be pregnant.
- •23 Woman of childbearing potential who is unwilling to use adequate contraceptive measures unless abstinence is considered adequate in the opinion of the investigator 24 Subjects on triple therapy on all combinations.
结局指标
主要结局
1 Mean change in trough FEV1
时间窗: 1 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 2 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 3 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 4 From baseline to 24 weeks | 5 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 6 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 7 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 8 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 9 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 10 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks | 11 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 12 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks
2 Mean change in trough FVC
时间窗: 1 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 2 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 3 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 4 From baseline to 24 weeks | 5 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 6 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 7 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 8 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 9 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 10 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks | 11 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 12 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks
3 Mean change in CAT scores
时间窗: 1 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 2 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 3 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 4 From baseline to 24 weeks | 5 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 6 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 7 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 8 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 9 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 10 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks | 11 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 12 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks
4 Proportion of subjects with a more than equal to 2 unit decrease in CAT
时间窗: 1 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 2 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 3 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 4 From baseline to 24 weeks | 5 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 6 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 7 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 8 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 9 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 10 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks | 11 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 12 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks
5 Proportion of subjects classified based on CAT severity as Low 0 to 10 medium 11 to 20 high 21 to 30 and very high 31 to 40
时间窗: 1 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 2 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 3 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 4 From baseline to 24 weeks | 5 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 6 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 7 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 8 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 9 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 10 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks | 11 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 12 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks
6 Mean change in R5 R5 minus R20 X5 Ax difference in X5 and Fres
时间窗: 1 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 2 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 3 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 4 From baseline to 24 weeks | 5 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 6 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 7 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 8 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 9 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 10 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks | 11 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 12 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks
7 Mean change in R5 R5 minus R20 and AX
时间窗: 1 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 2 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 3 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 4 From baseline to 24 weeks | 5 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 6 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 7 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 8 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 9 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 10 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks | 11 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 12 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks
8 Mean change in SGRQ C scores
时间窗: 1 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 2 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 3 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 4 From baseline to 24 weeks | 5 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 6 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 7 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 8 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 9 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 10 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks | 11 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 12 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks
9 Mean change in mMRC grades
时间窗: 1 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 2 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 3 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 4 From baseline to 24 weeks | 5 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 6 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 7 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 8 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 9 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 10 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks | 11 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 12 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks
10 Number of mild or moderate or severe exacerbations
时间窗: 1 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 2 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 3 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 4 From baseline to 24 weeks | 5 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 6 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 7 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 8 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 9 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 10 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks | 11 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 12 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks
11 Requirement of rescue medications and frequency
时间窗: 1 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 2 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 3 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 4 From baseline to 24 weeks | 5 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 6 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 7 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 8 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 9 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 10 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks | 11 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 12 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks
12 Adverse events treatment emergent adverse events and serious adverse events
时间窗: 1 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 2 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 3 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 4 From baseline to 24 weeks | 5 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 6 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 7 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 8 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 9 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 10 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks | 11 From Baseline V0 or Randomization V1 to V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline | 12 At V2 which is 4 weeks from baseline V3 is 12 weeks from baseline and V4 is 24 weeks from baseline or during the course of 24 weeks
次要结局
- NA(NA)
研究者
Dr Sundeep Salvi
Chest Research and Training (CREST)