An international, open, randomized, comparative study of the efficacy and safety of the medicinal products Glycopyrronium bromide 50 μg inhalation powder capsules (PSK Pharma LLC, Russia) and Seebri® Breezhaler® 50 μg inhalation powder capsules (Novartis Pharma AG , Switzerland) in subjects with COPD
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- The variation value for FEV1 indicator
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
Drug therapy for COPD is used to prevent and control the symptoms of the disease, improve the subjects life quality, reduce the frequency and severity of exacerbations, and reduce the frequency of deaths [3, 4]. Bronchodilator therapy is the basis for the treatment of Chronic Obstructive Pulmonary Disease (COPD). According to the GOLD recommendations, long-acting bronchodilators are indicated as the basic therapy for COPD, starting from stage II. There are two classes of inhaled medicinal products with a bronchodilator effect: 1) β2 agonists; 2) M-anticholinergics. Glycopyrronium is an anticholinergic medicinal product with a potent, rapidly onset bronchodilatory effect for the treatment of chronic obstructive pulmonary disease (COPD). Glycopyrronium is available in powder form capsules for inhalation. Numerous studies have shown good tolerability of the medicinal product, including high cardiac safety with long-term use.
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 subject Information Sheet (PIS) for participation in a clinical study.
- •2 A diagnosis of moderate-grade COPD, established according to the GOLD guidelines, 2019, at least 12 months before the screening visit.
- •3 The increase in FEV1 is <12% of the due and <200 ml relative to the initial level 30 minutes after administration of 400 μg of salbutamol.
- •4 Smoking subjects or those who smoked in the past more than 10 pack/years 5 The absence of exacerbation of COPD, associated with a change in therapy within 4 weeks prior to the screening visit.
- •6 The ability to correctly perform the inhalation procedure with the investigational medicinal products.
- •7 Body Mass Index (BMI) <35 kg/m2 at the time of the screening visit.
- •8 Consent of the subject to the use of reliable methods of contraception throughout the study and within 3 weeks after its completion.
排除标准
- •1 Subjects requiring initial treatment for COPD.
- •2 Hypersensitivity to Glycopyrronium bromide or any of the components of the drug.
- •3 Lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
- •4 Demand for excessive use of SABAs 5 Subjects get treated therapy with β-adrenergic blockers for 1 week before the screening visit and in need of their use.
- •6 Conditions requiring the use of systemic glucocorticosteroids (GCS).
- •7 The demand for long-term (daily at least 12 hours a day) oxygen therapy for chronic hypoxia.
- •8 Administration of oral or parenteral GCS in the previous 2 months before the screening visit (3 months for parenteral GCS of the extended release).
- •9 Glaucoma.
- •10 Bronchial asthma.
- •12 Respiratory infection and/or moderate or severe exacerbation of COPD and/or exacerbation of COPD, associated with antibiotic therapy, occurring at the time of the screening visit.
- •13 Pulmonary tuberculosis (active or inactive form).
- •14Cystic fibrosis, bronchiectasis, pneumoconiosis, or other history of lung ventilation limitations.
- •15 Found deficiency of α1-antitrypsin.
结局指标
主要结局
The variation value for FEV1 indicator
时间窗: at Visits 1 and 4
次要结局
- Dynamics of FEV1 indicator(for Visits 2, 3 and 4)
- Dynamics of the absolute PEF indicator(for Visits 2, 3 and 4.)
- The frequency of subjects with exacerbations(Visits 2, 3, and 4)
- Dynamics of the total CAT score(for Visits 2, 3, and 4.)
- Dynamics of the severity of dyspnea according to the MRC scale(for Visits 2, 3, and 4.)