An international, open, randomized, comparative study of the efficacy and safety of the medicinal products Glycopyrronium bromide 50 Î¼g inhalation powder capsules (PSK Pharma LLC, Russia) and SeebriÂ® BreezhalerÂ® 50 Î¼g inhalation powder capsules (Novartis Pharma AG , Switzerland) in subjects with COPD

PSK Pharma LLC0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年2月21日

试验速览

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•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 Î¼g 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.

•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 Î²-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.
•11 Allergic rhinitis, atopic eczema or dermatitis in the acute stage.
•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 Î±1-antitrypsin.

发起方

PSK Pharma LLC