CTRI/2021/08/035351尚未招募3 期
International open multicenter randomized comparative study of pharmacokinetics, efficacy and safety of the medications Respinid® (INN: budesonide), metered dose inhaler suspension, 0.5 mg/ml (BML PARENTERAL DRUGS, India) and Pulmicort®, metered dose inhaler suspension, 0.5 mg/ml (AstraZeneca AB, Sweden) in patients with partially controlled bronchial asthma
PSK Pharma LLC1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2021年5月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- The variation value for FEV1 indicator
研究概览
简要总结
Bronchial asthma (BA) – heterogeneous disease that is characterized by chronic inflammation of the airways and is accompanied by respiratory symptoms such as sibilant rale, shortness of breath, chest congestion, and coughing. These symptoms vary in time and intensity and manifest along with variable airway obstruction
One of the most effective and safe medications in this group is budesonide. Its distinctive features among other iGCSs are high activity against HA-receptors, intermediate lipophilicity and prolonged tissue retention due to conjugation with fatty acids
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 ACQ-5 questionnaire results ≥ 0.75 and < 1.5 points
- •The indicator of the forced expiratory volume in 1 second (FEV1) before taking bronchodilators is at least 60% of the due.
- •A controller therapy of BA with low doses of iGCS for at least 1 month before the screening visit.
排除标准
- •Patients in need of selection of starting maintenance therapy for BA.
- •Contraindications to the treatment of iGCS, hypersensitivity to budesonide, salbutamol or any components of the investigational medication, reference medication and salbutamol medication.
- •Body mass index (BMI) > 35 kg/m2.
结局指标
主要结局
The variation value for FEV1 indicator
时间窗: at Visits 1 and 4
次要结局
- Dynamics of FEV1 indicator(for Visits 2, 3 and 4.)
- Dynamics of the absolute PEF indicator(for Visits 2, 3 and 4.)
- Dynamics of the total score on the ACQ-5 BA control questionnaire(at Visits 2, 3 and 4.)
- Dynamics of quality of life indicators according to the SF-36 questionnaire(at Visits 2 and 4.)
- The frequency of patients who experienced exacerbations according to the classification of the severity of exacerbations(at Visits 2, 3 and 4.)
- The frequency of patients who achieved BA control (total score in the ACQ-5 questionnaire 0.75)(by Visit 4.)
- Weekly average daily need for SABAs (μg/day) (medication salbutamol)(by Visit 2, 3 and 4.)
研究者
研究点 (1)
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