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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- FEV1
研究概览
简要总结
The study will be conducted as an open-label, multicentre, randomized,comparative trial.
The total duration of the study for each patient will notexceed 109 days, of which the duration of screening will not exceed 14 days, the duration of the treatment period - 84 days, and the duration ofthe follow-up period - 11 days.
Visits
Visit 0 (screening, Day -14 ... -1); Visit 1 (randomization, Day 1) ; Visit 2 (interim visit, 28 ± 2 days); Visit 3 (interim visit, 56 ± 2 days); Visit 4 (completion of therapy, 86 ± 2 days); Visit 5 (telephonecall, 93 ± 2 days).
The 1st group of patients will receive 1 inhalation (one capsule) ofTiotropium bromide, inhalation powder capsules, 18 µg (Sava Healthcare Limited,India), once daily (at the same time) for 84 days, performed using an inhaler.
The 2nd group of patients willreceive 1 inhalation (one capsule) of Spiriva®, inhalation powdercapsules, 18 µg (Boehringer Ingelheim Pharma GmbH & Co. KG, Germany), oncedaily (at the same time) for 84 days, performed using an inhaler.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
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 ≥
- •4 Number of exacerbations per year: 0 –
- •5 Patient’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.
结局指标
主要结局
FEV1
时间窗: change at Visit 4
次要结局
- FEV1(Changes at Visits 2, 3, and 4)
- Proportion of patients with exacerbated disease(Proportion of patients with exacerbated disease at Visits 2, 3, and 4)
- Absolute PEF value(Changes in the absolute PEF value by Visits 2, 3, and 4.)
- Total CAT score(Changes in the total CAT score by Visits 2, 3, and 4.)
- Dyspnoea severity score(Changes in the dyspnoea severity score assessed with the MRC scale by Visits 2, 3, and 4.)