International, open-label randomized comparative study of the efficacy and safety of Ciclesonide metered-dose inhaler, 160 Î¼g/dose (LLC â??PSK Pharmaâ??, Russia) and Alvesco, metered-dose inhaler, 160 Î¼g/dose (AstraZeneca AB, Sweden) in patients with partially controlled asthma

PSK Pharma LLC0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•ACQ-5 asthma control test result: >= 0.75 and <1.5
•Forced expiratory volume - 1 second (FEV1) before the use of broncholytics not less than 60% of proper value (at screening visit or at the moment of test within 30 days before screening visit).
•Positive result of the test for reversibility of airway obstruction, expressed as Î?FEV1 >=12% and >=200 ml vs. baseline 30 minutes after the use of 400 Âµg of Salbutamol.
•Signed Informed consent form for participation in the clinical study in the Patients Information Sheet

•Patients with the need for selection of initial maintenance therapy of BA.
•Contraindications to the use of iGCS, hypersensitivity to Ciclesonide, Salbutamol or any components of the study product
•Use of glucocorticosteroids, either oral or for parenteral administration, less than 2 months before the screening visit (3 months for parenteral long-acting GCS).
•Use of immunosuppressors less than 4 weeks before the screening visit (e.g. cyclosporine, methotrexate, anti-tumor necrosis factor Î±-receptors (TNF), gold preparations, azathioprine etc.).
•Conditions requiring the use of systemic GCS at the time of the screening visit.
•Unexpected and progressive deterioration of control of symptoms of BA.
•Unstable course of bronchial asthma, hospitalization due to exacerbation of bronchial asthma in the intensive care unit using intubation, frequent exacerbations of asthma
•Pulmonary tuberculosis (active or inactive form).
•Fungal, viral or bacterial respiratory infections or systemic viral infections, herpetic ocular lesions (Herpes simplex) at the time of the screening visit.
•Infection of the lower respiratory tract less than 1 month before the screening visit.
•1Cystic fibrosis, bronchiectasis, pneumoconiosis.
•Restrictive type breathing disorders.
•Uncontrolled hypokalemia, hypocalcemia.
•Thyrotoxicosis.
•Decompensated diabetes mellitus.
•Osteoporosis.
•Glaucoma, cataract.

发起方

PSK Pharma LLC