CTRI/2020/09/027824暂停不适用
International, open-label randomized comparative study of the efficacy and safety of Ciclesonide metered-dose inhaler, 160 μg/dose (LLC “PSK Pharmaâ€, Russia) and Alvesco, metered-dose inhaler, 160 μg/dose (AstraZeneca AB, Sweden) in patients with partially controlled asthma
PSK Pharma LLC1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2020年9月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change in the PEF1 value
研究概览
简要总结
Bronchial asthma is a heterogeneous disease, characterized by chronic inflammation of therespiratory tract, and accompanied by respiratory symptoms such as wheezing,dyspnea, chest congestion and cough. These signs vary in duration and intensityand manifest along with variable airway obstruction
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Toassess the efficacy of treatment with Ciclesonide, metered-dose inhaler in patients with partially controlled BA.
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Toassess the safety of treatment with Ciclesonide, metered-dose inhaler in patients with partially controlled BA.
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To assess the effect ofCiclesonide, metered-dose inhaler on the quality of life of patients withpartially controlled BA metered-dose inhaler
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
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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 ΔFEV1 ≥12% and ≥200 ml vs. baseline 30 minutes after the use of 400 µg of Salbutamol. Signed Informed consent form for participation in the clinical study in the Patients Information Sheet.
排除标准
- •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 α-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.
结局指标
主要结局
Change in the PEF1 value
时间窗: Visits 1 and 4
次要结局
- Evolution of the PEF value(as measured at Visits 2, 3 and 4.)
- Changes in FEV1 value
- Changes of the index according to the ACQ-5 questionnaire for evaluation of BA control
- Changes in quality of life indicators (QOL) according to the SF-36 questionnaire(from baseline)
研究者
研究点 (1)
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