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临床试验/CTRI/2021/12/038978
CTRI/2021/12/038978尚未招募未知

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

PSK Pharma LLC0 个研究点目标入组 0 人开始时间: 待定最近更新:
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试验速览

阶段
未知
状态
尚未招募
发起方
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • •1. A diagnosis of moderate-grade COPD, established according to the GOLD guidelines, 2019, at least 12 months before the screening visit
  • •2. The absence of exacerbation of COPD, associated with a change in therapy within 4 weeks prior to the screening visit.
  • •3. The ability to correctly perform the inhalation procedure with the investigational medicinal products.
  • •4. 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.
  • •5. Smoking subjects or those who smoked in the past more than 10 pack/years
  • •6. The absence of exacerbation of COPD, associated with a change in therapy within 4 weeks prior to the screening visit.
  • •7. Body Mass Index (BMI) <35 kg/m2 at the time of the screening visit.

排除标准

  • •1. Subjects requiring initial treatment for COPD.
  • •2. Hypersensitivity to Glycopyrronium bromide, Indacaterol or any of the components of the medicinal product.
  • •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.
  • •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).
  • •14. Cystic fibrosis, bronchiectasis, pneumoconiosis, or other history of lung ventilation limitations.
  • •15. Found deficiency of α1-antitrypsin.
  • •16. A history of lung resection or lung transplantation.
  • •17. 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.
  • •18. Myocardial infarction, stroke, or thromboembolism for 6 months before inclusion in the study.

研究者

发起方
PSK Pharma LLC

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