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临床试验/CTRI/2020/12/030118
CTRI/2020/12/030118尚未招募3 期

International, open-label, randomized, comparative efficacy and safety study of Indacaterol, inhalation capsules 150 µg (LLC PSK Pharma, Russia) and Onbrez® Breezhaler®, inhalation capsules 150 µg (Novartis Pharma AG, Switzerland) in patients with COPD

PSK Pharma LLC0 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
3 期
状态
尚未招募
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.The presence of a signed Informed Consent Form of Patient Information Sheet (PIS) for participation in a clinical study.
  • 2.Male and female patients aged 40â??70 years old inclusive at the time of signing the Informed Consent Form of PIS.
  • 3.A diagnosis of moderate-grade COPD, established according to the GOLD guidelines, 2018, at least 12 months before the screening visit.
  • 4.Patients corresponding to group B, according to GOLD, 2018

排除标准

  • 1.Patients requiring initial treatment for COPD.
  • 2.Hypersensitivity to indacaterol or any of the components of the drug.
  • 3.Lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
  • 4.Demand for excessive use of SABAs

研究者

发起方
PSK Pharma LLC

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