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).

Cipla Ltd0 个研究点目标入组 356 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 3 期
状态: 已完成
发起方: Cipla Ltd
入组人数: 356

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1. A voluntarily given, written, signed, and dated Informed Consent from subject and/or legally acceptable representative.
•2. Subjects of either gender and age between 40 and 65 years (both inclusive)
•3. 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
•4. Post-bronchodilator FEV1 >= 40% and <= 80% of the predicted normal value
•5. Post bronchodilator FEV1/FVC ratio of <0.7
•6. Current or ex-smoker of at least 10 pack years of cigarette/ biddi smoking
•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
•2. Subjects with any hospitalization required for exacerbation or any serious condition in the previous 12 weeks
•3. Subjects who had more than two exacerbations in past 1 year
•4. Use of systemic corticosteroids/antibiotics in prior 6 weeks
•5. Subjects requiring oxygen therapy
•6. Clinically significant ECG abnormality
•7. Absolute Blood eosinophil count >600 cells/c mm of blood.
•8. 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
•9. History of asthma or any chronic respiratory disease other than COPD.
•10. Occupational and non-smoking COPD
•11. Life-threatening/unstable respiratory disease, including lower respiratory tract infection, within the previous 4 weeks.
•12. History of lung resection of more than one full lobe.
•13. Scheduled for in-patient hospitalization, including elective surgery during the trial.
•14. Clinically significant laboratory values, as judged by the investigator.
•15. History of clinically significant bladder neck obstruction or urinary retention
•16. History of uncontrolled glaucoma
•17. History of uncontrolled diabetes mellitus
•18. Subjects receiving immunotherapy or live vaccine within past 1 year and inactivated vaccine within 1 month from screening visit 1
•19. Participation in clinical trial in prior 4 weeks of screening visit 1.
•20. Participation in clinical trial of Glycopyrronium alone or in combination within past 3 months of screening visit 1
•21. Female who is pregnant or lactating or planning to be pregnant.
•22. Woman of childbearing potential who is unwilling to use adequate contraceptive measures unless abstinence is considered adequate in the opinion of the investigator.

研究者

发起方

Cipla Ltd

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