CTRI/2020/01/022780招募中4 期
Study on Comparison of Safety and Efficacy of Glycopyrrolate/Formoterol versus Tiotropium/Formoterol in Patients with COPD.
SRM COLLEGE OF PHARMACY SRMIST0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
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.Ex-smokers
- •2.Clinical history of moderate to severe COPD, (Global Initiative for Chronic Obstructive Lung Disease [GOLD] Stage II or III according to 2019 GOLD guidelines)
- •3.Post bronchodilator forced expiratory volume in 1 second (FEV1 ) >= 30% and <80% of predicted
- •4.Post bronchodilator FEV1/forced vital capacity (FVC) <0.70 at screening
排除标准
- •1.Pregnant and lactating women
- •2.Known history of psychiatric illness
- •3.Moderate or severe renal impairment
- •4.Patients with urinary retention
- •5.Narrow-angle glaucoma
- •6.Known history of alpha-1 antitrypsin deficiency
- •7.Other underlying respiratory diseases other than COPD
- •8.Surgeries including lobectomy or bronchoscopic lung volume reduction
- •9.Inability to produce acceptable/reproducible spirometry results
- •10.Contraindications to Glycopyrrolate, Formoterol or Tiotropium
- •11.History of adverse reactions to inhaled anticholinergics
- •12.Patients with known malignancies
研究者
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