NCT01274325已完成3 期
Comparison of Anti-inflammatory Effects of Seroflo 125 Inhaler With Seretide Evohaler(25/125) in Patients With Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Sputum eosinophils
研究概览
简要总结
The purpose of this study is to test hypothesis if Sereflo (ICS/LABA) could reduce airway inflammation in asthmatic patients in the same as Seretide.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20-80 years
- •Patients with asthma diagnosed by according to the American Thoracic Society criteria
- •A baseline FEV1 > or = 50% predicted with a reversibility of FEV1 after therapy with inhaled salbuterol (2.5 mg) of FEV1 12% or with provocative concentration of a methacholine causing a 20% fall in FEV1 (PC20) of < or = 8 mg/mL
- •Prescribed use of inhaled corticosteroids (any brand) for at least 12 weeks prior to study entry
- •The daily prescribed dose of inhaled corticosteroids during the last 4 weeks prior to study entry should have been constant and at least 250 μg/day of fluticasone at least 400 μg/day of budesonide at least 500 μg/day of any other beclomethasone
- •Be able to provide written informed consent
排除标准
- •Any asthma exacerbation or respiratory tract infection affecting asthma within 4 weeks prior to the randomization visit
- •Intake of oral, parenteral corticosteroids within 4 weeks and/or depot parenteral corticosteroid within 12 weeks prior to the randomization visits
- •Current or previous smoker with a smoking history of > or = 10 pack years
- •Previous randomization of treatment in the present study
- •Known or suspected hypersensitivity to study therapy
- •Use of any β-blocking agent, including eye-drops
- •Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive pill measures
研究组 & 干预措施
Sereflo
Experimental
Sereflo (25/125)
干预措施: Sereflo (Drug)
Seretide
Active Comparator
Seretide (25/125)
干预措施: Seretide (Drug)
结局指标
主要结局
Sputum eosinophils
时间窗: 4 weeks
次要结局
- Exhaled nitric oxide(4 weeks)
- Asthma control test scores(4 weeks)
研究者
Kittipong Maneechotesuwan
Professor
Mahidol University
研究点 (2)
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