CTRI/2017/10/010024尚未招募未知
An open-label, multicentre, randomized, comparative study of the efficacy and safety of Tiotropium bromide, inhalation powder capsules, 18 µg (Sava Healthcare Limited, India), versus Spiriva®, inhalation powder capsules, 18 µg (Boehringer Ingelheim Pharma GmbH & Co. KG, Germany) in patients with COPD.
Rus Biopharm 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
- 未知
- 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 Male and female patients 40 to 75 years of age.
- •2 Diagnosis of COPD established according to the GOLD guidelines (2015) not less than 12 months prior to the screening visit.
- •3 COPD assessment test (CAT) score >= 10.
- •4 Number of exacerbations per year: 0 â?? 1.
- •5 Patientâ??s consent to use reliable methods of contraception throughout the study and for 3 weeks after the study
排除标准
- •1 Hypersensitivity to atropine, its derivatives (ipratropium, oxitropium) or to any component of the study drugs.
- •2 Lactose intolerance, lactase deficiency, or glucose - galactose malabsorption.
- •3 Use of oral or parenteral glucocorticoids (GC) within 2 months prior to the screening visit (3 months for prolonged-release parenteral GC).
- •4 A history of cystic fibrosis, bronchiectasis, pneumoconiosis, or other impairment of pulmonary ventilation.
研究者
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