CTRI/2017/08/009286已完成3 期
A randomized, prospective, open label, comparative, parallel group, multicentre 12 weeks study to evaluate efficacy, safety and tolerability of Glycopyrronium/Formoterol FDC 25mcg/12mcg twice daily in comparison with Glycopyrronium 50mcg once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 360
- 试验地点
- 33
- 主要终点
- Mean change in pre dose trough FEV1
研究概览
简要总结
This is randomized, prospective, open label, comparative, parallelgroup, multicentre, phase III study to evaluate efficacy, safety andtolerability of Glycopyrronium/Formoterol FDC 25mcg/12mcg twice daily comparedwith Glycopyrronium 50mcg once daily. 360 subjects of moderate to severe COPDwill be randomized considering 30% dropout and will be receive eitherGlycopyrronium/Formoterol FDC or Glycopyrronium treatment for 12 weeks.
Primary outcome is Mean change in pre-dose trough FEV1at 12 weeks of treatment from baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •A voluntarily given, written, signed, and dated Informed Consent from subject and/or legally acceptable representative.
- •Subjects of either gender and age between 40 and 65 years (both inclusive)
- •Subjects with moderate to severe COPD (GOLD 2015).
- •Subjects should have a documented history of COPD and spirogram within at least the past 6 months
- •Post-bronchodilator FEV1 ≥ 40% and ≤ 80% of the predicted normal value
- •Post bronchodilator FEV1/FVC ratio of <0.7
- •Subjects having ability to use pMDI and DPI during the course of the study and able to comply with the study protocol.
排除标准
- •1.Hypersensitivity to Glycopyrronium or Formoterol or Levosalbutamol or Budesonide or Ipratropium or any of its components
- •Subjects with any hospitalization required for exacerbation or any serious condition in the previous 12 weeks
- •Subjects who had more than two exacerbations in past 1 year
- •Subjects requiring oxygen therapy
- •Clinically significant ECG abnormality
- •Absolute Blood eosinophil count >600 cells/c mm of blood.
- •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
- •History of asthma or any chronic respiratory disease other than COPD.
- •Life-threatening/unstable respiratory disease, including lower respiratory tract infection, within the previous 4 weeks.
- •History of lung resection of more than one full lobe.
- •Scheduled for in-patient hospitalization, including elective surgery during the trial.
- •Clinically significant laboratory values, as judged by the investigator.
- •History of clinically significant bladder neck obstruction or urinary retention
- •History of uncontrolled diabetes mellitus
- •Subjects receiving immunotherapy or live vaccine within past 1 year and inactivated vaccine within 1 month from screening visit 1
- •Participation in clinical trial in prior 4 weeks of screening visit
- •Participation in clinical trial of Glycopyrronium alone or in combination within past 3 months of screening visit 1
- •Female who is pregnant or lactating or planning to be pregnant.
- •Woman of childbearing potential who is unwilling to use adequate contraceptive measures unless abstinence is considered adequate in the opinion of the investigator.
结局指标
主要结局
Mean change in pre dose trough FEV1
时间窗: At 12 weeks of treatment from baseline
次要结局
- Mean change in 1 hour post dose FEV1 and FVC(At 2, 4, 8 and 12 weeks of treatment from baseline)
- Mean change in pre dose trough FVC(At 2, 4, 8 and 12 weeks of treatment from baseline)
- Mean change in pre dose trough FEV1(At 2, 4, and 8 weeks of treatment from baseline)
- Difference in average daily number of pMDI puffs of rescue medication consumed(At 2, 4, 8 and 12 weeks of treatment from baseline)
- Mean change in mMRC scale(At 4, 8 and 12 weeks of treatment from baseline)
- Mean change in CAT score(At 4, 8 and 12 weeks of treatment from baseline)
- Mean change in COPD and Asthma Sleep Impact Scale (CASIS) score(At 4, 8 and 12 weeks of treatment from baseline)
研究者
研究点 (33)
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