NCT01076322已完成3 期
A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler® and Ventolin® MDI in Stable Asthma Patients
Taiwan Otsuka Pharm. Co., Ltd1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2009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
- 17
- 试验地点
- 1
- 主要终点
- The change in 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 Ventolin® MDI 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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or females outpatients aged ≥ 16 years old with stable mild to moderate persistent asthma; Stability was assessed the patient remained in the same severity class (mild, moderate) and had no acute exacerbations by investigator judgment during the past 14 days;
- •Pulmonary function test:
- •Improvement ≥12% reversibility in FEV1 or FVC following administration of an inhaled β2-agonist before the study or ;
- •Positive result of Broncho-provocation test (PC20 ≤ 32 mg/ml) before the study.
- •Baseline forced expiratory volume in one second 60% ≤(FEV1)≤ 90% of predicted value on entry of the study;
排除标准
- •Hypersensitivity to β2-agonist or lactose;
- •Hospitalization due to asthma during the previous 3months;
- •Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;
- •Oral or systemic corticosteroids in the previous 4weeks;
- •Inadequately controlled hyperthyroidism;
- •Severe hepatic or renal or cardiovascular disease as judged by the investigator;
- •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).
研究组 & 干预措施
Treatment-A sequence
Experimental
Meptin® Swinghaler / Ventolin® MDI
干预措施: Meptin® Swinghaler (Drug)
Treatment-A sequence
Experimental
Meptin® Swinghaler / Ventolin® MDI
干预措施: Ventolin® MDI (Drug)
Treatment-B sequence
Experimental
Ventolin® MDI / Meptin® Swinghaler
干预措施: Meptin® Swinghaler (Drug)
Treatment-B sequence
Experimental
Ventolin® MDI / Meptin® Swinghaler
干预措施: Ventolin® MDI (Drug)
结局指标
主要结局
The change in Forced Expiratory Volume in 1 second (FEV1) value.
时间窗: 2 days
次要结局
- The change in sGaw(2 days)
- The changes in IOS parameters (R, X and RF)(2 days)
- The change in Peak Expiratory Flow Rate (PEFR)(2 days)
- The change in Forced Vital Capacity (FVC)(2 days)
- The change in Oxygen Saturation (SpO2)(2 days)
- The change in Borg scale(2 days)
- Device acceptance(2 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal CancerMetastatic Colorectal CancerNCT01008475Merck KGaA, Darmstadt, Germany232
已完成
3 期
Neoadjuvant Chemo-endocrine Therapy Versus Chemotherapy Alone in ER-positive, HER2-negative Breast CancerBreast Cancer FemaleNCT02980965Fudan University249
已完成
不适用
A Pilot Study to Evaluate the Safety and Effectiveness of Microneedling and Bellafill to Treat Facial Acne ScarsAtrophic Acne ScarsNCT02643628Suneva Medical, Inc.45
Unknown
不适用
Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary RevascularizationIschemic Heart DiseaseCoronary Artery Lesions,PrimaryCoronary DiseaseFurcation Lesion of Coronary ArteryAcute Coronary SyndromeMyocardial IschemiaNCT01681381Essen Technology (Beijing) Co., Ltd.2,790
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler and Berotec N® Metered Aerosol in Mild to Moderate Stable Asthma PatientsAsthmaNCT01095016Taiwan Otsuka Pharm. Co., Ltd32