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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- FEV1 variation value
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is a disease characterized by airflow restriction with the development of not completely reversible bronchial obstruction. Airflow restriction is progressing and is associated with an enhanced pathological inflammatory response of the respiratory tract to damaging particles or gases
To evaluate the efficacy of therapy with Indacaterol inhalation powder capsules in comparison with Onbrez® Breezhaler® inhalation powder capsules in patients with COPD.
To evaluate the safety of therapy with Indacaterol inhalation powder capsules in comparison with Onbrez® Breezhaler® inhalation powder capsules in patients with COPD.
To evaluate the effect of Indacaterol inhalation powder capsules in comparison with Onbrez® Breezhaler® inhalation powder capsules on the quality of life of patients with COPD.
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 70.00 Year(s)（—）
- 性别
- All
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 40–70 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.
结局指标
主要结局
FEV1 variation value
时间窗: AT 86th day
次要结局
- Dynamics of the absolute PEF indicator(at 28th, 56th and 86th Day)
- Dynamics of the total CAT score(at 28th, 56th and 86th Day)
- Dynamics of FEV1 indicator(at 28th, 56th and 86th Day)