NCT02491970终止4 期
A Single-blind, Randomized, Active-controlled, Multi-center and Phase IV Study to Evaluate the Small Airway Parameters of Fluticasone/Formoterol (Flutiform®) Compared to Fluticasone/Salmeterol in Asthma Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 15
- 主要终点
- Efficacy superiority as measured by Impulse Oscillometric System
研究概览
简要总结
The purpose of this study is to demonstrate superiority of Fluticasone/Formoterol (Flutiform®) to Fluticasone/salmeterol based on the small airway function by assessing the Impulse Oscillometic System (IOS) in uncontrolled asthma patients requiring ICS/LABA concomitant treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (over 19 years) asthma patients
- •Patients who have a history of mild-to-moderate-severe, persistent asthma for at least 6 months prior to Screening.
- •Patients who were required to demonstrate a FEV1 of ≥ 40 % and ≤ 85% of predicted normal values during screening period following appropriate withholding of asthma medications (if applicable).
- •Patients who were required to show reversibility of ≥15% FEV1 after salbutamol inhalation (2 actuations, 100µg per actuation) from the pre- salbutamol value at screening
- •Patients who have uncontrolled asthma by Seretide® 250/50 defined as ACT less than 20
- •Patients who showed R5-20 more than 0.1 kPa/L/s
- •Blood eosinophil count > 300/µL on screening visit
- •Female patients of childbearing potential must have a negative urine pregnancy test at Screening.
- •Patients who are able to use the inhaler
- •Patients who is willing to voluntarily sign the study consent form
排除标准
- •Patients who have experienced life-threatening asthma within 12 months prior to screening or respiratory infection within 4 weeks prior to screening, or patients who have experienced any emergency visit or hospitalization due to acute asthma symptoms within 4 weeks prior to screening
- •Patients who have diagnosed as clinically significant disease or non- reversible pulmonary disease or patients who currently have active pulmonary disease (eg. COPD, cystic fibrosis, bronchiectasis, active tuberculosis)
- •Patients who have diagnosed as laryngitis, chronic sinusitis, infectious rhinitis or allergic rhinitis within 4 weeks prior to screening, or patients who have had any symptoms of acute exacerbation or purulent discharge by the disease above within 2 weeks prior to screening
- •Current smoker or past smoker defined as below:
- •Current smoker: smoking history within 12 months prior to screening
- •Past smoker: smoking amount ≥10 pack year*
- •Pack year (PY) calculation: average amount of smoking per day (pack) x duration of smoking (year)
- •Patients who currently are pregnant or lactating
- •Patient who had taken systemic corticosteroid within 4 weeks prior to screening
- •Patients who had taken omalizumab within 24 weeks prior to screening
- •Patients who had taken the following medications within 1 week prior to screening:
- •potent CYP3A inhibitors
- •β-blockers
- •monoamine oxidase inhibitor
- •TCA (tricyclic antidepressants)
- •quinidine-type anti arrhythmic
- •Leukotriene anatagonist
- •Astemizole
- •Patients who are participating or going to participate in any interventional clinical trials
- •QT interval prolongation in ECG result at screening
- •Patients with hypersensitive to investigational products or to any component of the drug
- •Patients who are judged difficult to participate in this investigation by the investigator
研究组 & 干预措施
Fluticasone/Formoterol
Experimental
Brand name: Flutiform Dose: 250/10μg (2 puffs/once, BID) Duration of treatment: 12 weeks Mode of administration: oral inhalation
干预措施: Fluticasone/Formoterol (Drug)
Fluticasone/Salmeterol
Active Comparator
Brand name: Seretide Dose: 250/50μg (2 puffs/once, BID) Duration of treatment: 12 weeks Mode of administration: oral inhalation
干预措施: Fluticasone/Salmeterol (Drug)
结局指标
主要结局
Efficacy superiority as measured by Impulse Oscillometric System
时间窗: 12 weeks
To compare Fluticasone/Formoterol to Fluticasone/salmeterol, assessing the change in the mean R5-R20 measured by the Impulse Oscillometic System (IOS) in uncontrolled asthma patients
次要结局
- Incidence of adverse drug reactions as a measure of safety(12 weeks)
研究者
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