An International, Open, Randomized, Comparative study of the efficacy and safety of the medicinal products Glycopyrronium bromide plus Indacaterol 50 plus 110 μg inhalation powder capsules (PSK Pharma LLC, Russia) and Ultibro Breezhaler 50 plus 110μg inhalation powder capsules(Novartis Pharma AG, Switzerland) in subjects with COPD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- FEV1 variation
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 [1, 2].
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. Indacaterol ‒ the first representative of β2-adrenergic agonists with a rapid, after 5 minutes, onset of action and a long, within 24 hours, action, registered in Russia in early 2011 (the medicinal product was first registered in Europe on November 30, 2009). The rapid onset of action and the duration of the bronchodilation effect of the medicinal product are associated with the affinity of the molecule for the lipid structures of the cell, near which β2-receptors (so-called lipid rafts) are located. In accordance with this concept, the receptors and effectors are combined into one signal platform, which ensures the efficiency and selectivity of signal transmission [5]. 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
- •A diagnosis of moderate-grade COPD, established according to the GOLD guidelines, 2019, at least 12 months before the screening visit
- •The absence of exacerbation of COPD, associated with a change in therapy within 4 weeks prior to the screening visit.
- •The ability to correctly perform the inhalation procedure with the investigational medicinal products.
- •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.
- •Smoking subjects or those who smoked in the past more than 10 pack/years
- •Body Mass Index (BMI) <35 kg/m2 at the time of the screening visit.
排除标准
- •Subjects requiring initial treatment for COPD.
- •Hypersensitivity to Glycopyrronium bromide, Indacaterol or any of the components of the medicinal product.
- •Lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
- •Demand for excessive use of SABAs
- •Subjects get treated therapy with β-adrenergic blockers for 1 week before the screening visit and in need of their use.
- •Conditions requiring the use of systemic glucocorticosteroids (GCS).
- •The demand for long-term (daily at least 12 hours a day) oxygen therapy for chronic hypoxia.
- •Administration of oral or parenteral GCS in the previous 2 months before the screening visit (3 months for parenteral GCS of the extended release).
- •Bronchial asthma.
- •Allergic rhinitis, atopic eczema or dermatitis in the acute stage.
- •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.
- •Pulmonary tuberculosis (active or inactive form).
- •Cystic fibrosis, bronchiectasis, pneumoconiosis, or other history of lung ventilation limitations.
- •Found deficiency of α1-antitrypsin.
- •A history of lung resection or lung transplantation.
- •Class III-IV chronic heart failure according to the classification of the New York Heart Association (NYHA); uncontrollable hypertension; unstable angina, unstable or first diagnosed arrhythmia; tachy-arrhythmia; ischaemic heart disease; myocarditis; aortic stenosis.
- •Myocardial infarction, stroke, or thromboembolism for 6 months before inclusion in the study.
结局指标
主要结局
FEV1 variation
时间窗: at Visit 4
次要结局
- Dynamics of FEV1 indicator(Visits 2, 3 and 4)
- Dynamics of the absolute PEF indicator(for Visits 2, 3 and 4.)
- Dynamics of the total CAT score(for Visits 2, 3, and 4.)
- Dynamics of quality of life (QOL) indicators according to the questionnaire SGRQ(Visits 2, 3, and 4.)