CTRI/2021/08/035992进行中（未招募）4 期
An open label, prospective, non-comparative, multicenter, 24 weeks, phase IV trial to evaluate safety and efficacy of Glycopyrronium/Formoterol/Budesonide (25mcg/12mcg/400mcg) fixed dose triple combination (FDC) twice daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). - NA
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- Cipla Ltd
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 75 years (both inclusive).
- •3. Subjects with a documented history of COPD (GOLD 2020 guidelines)-based on spirogram within past one year from screening.
- •4. Post-bronchodilator FEV1 greater than or equal to 30% and less than or equal to 80% of the predicted normal value.
- •5. Post-bronchodilator FEV1/FVC ratio of less than 0.7.
- •6. Subjects with CAT score greater than 10.
- •7. Current or ex-smoker of at least 10 pack years of cigarette/ biddi smoking or subjects who had exposure to noxious stimuli which led to development of COPD.
- •8. Subjects having ability to use Revolizer® during course of the study and able to comply with protocol.
排除标准
- •1. Hypersensitivity to glycopyrronium or formoterol or budesonide or levosalbutamol or any of its components.
- •2. Subjects with any hospitalization required for severe exacerbation or any serious condition within past 12 weeks from screening.
- •3. Subjects requiring oral/parenteral corticosteroids within past 4 weeks from screening.
- •4. Subjects requiring oxygen therapy (at least 12 hours daily) in past 4 weeks from screening.
- •5. Clinically significant ECG abnormality.
- •6. 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.
- •7. History of asthma (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.
- •8. Subjects on dual bronchodialator such as LABA/LAMA or SABA/SAMA or on tripe therapy for COPD within 3 months from screening.
- •9. Life-threatening/unstable respiratory disease, including lower respiratory tract infection, within past 4 weeks from screening.
- •10. History of lung resection of more than one full lobe.
- •11. Scheduled for in-patient hospitalization, including elective surgery during the trial.
- •12. Clinically significant laboratory values, as judged by the investigator.
- •13. History of clinically significant bladder neck obstruction or urinary retention.
- •14. History of glaucoma.
- •15. History of diabetes mellitus.
- •16. Participation in clinical trial in within past 4 weeks of screening.
- •17. Female who is pregnant or lactating or planning to be pregnant.
- •18. 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
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