NCT01095016已完成3 期
An Open-label, Randomized, Cross-over, Active-controlled Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler and Berotec N® Metered Aerosol in Mild to Moderate Stable Asthma Patients
Taiwan Otsuka Pharm. Co., Ltd1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The change of Forced Expiratory Volume in 1 second (FEV1) value
研究概览
简要总结
This is an open-label, randomized, cross-over, active-controlled study to evaluate the efficacy and safety effects using Meptin® Swinghaler and Berotec N® Metered Aerosol in stable asthma patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or females outpatients aged ≥18 years old with uncontrolled or partly controlled asthma; Stability was assessed during the past 14 days the patients remained in the same severity class by 2006 GINA guideline (uncontrolled, partly controlled) and had no acute exacerbations by investigator judgment;
- •Pulmonary function test: Improvement ≥12% reversibility in FEV1 or FVC following administration of an inhaled β2-agonist before the study or ; Positive result of Brocho-provocation test;
排除标准
- •Hypersensitivity to β2-agonist or lactose;
- •Hospitalization due to asthma during the previous 3 months;
- •Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;
- •Oral or systemic corticosteroids in the previous 4 weeks;
- •Inadequately controlled hyperthyroidism;
- •Subjects with any clinically significant disorder of the cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or immunologic system or respiratory disease other than asthma(e.g. COPD), or any other disorder which may interfere wth the study evaluations or affect subject safety;
- •Patients receive an investigational drug within 30 days prior to admission to the study;
- •Patients with significant alcohol, drug or medication abuse as judged by the investigator;
- •Females who are pregnant or breast-feeding; (exception: Females of child-bearing age might be included, if in the opinion of the investigator, they are using adequate contraceptive precautions);
- •Subjects who are heavy smoker (more than 10 packs year) or who are smoking within previous 6 months.
研究组 & 干预措施
Meptin swinghaler
Experimental
干预措施: Meptin swinghaler (Drug)
Berotec
Active Comparator
干预措施: Berotec (Drug)
结局指标
主要结局
The change of Forced Expiratory Volume in 1 second (FEV1) value
时间窗: 12 months
次要结局
- The change of Peak Expiratory Flow Rate (PEFR)(12 months)
- The change of Forced Vital Capacity (FVC)(12 months)
- Device acceptance(12 months)
研究者
研究点 (1)
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