NCT02148120已完成2 期
A Phase II, Multicentre, Double-blind, Randomised, 5-way Crossover Study to Test the Non-inferiority of the Acute Bronchodilator Effect of CHF 1535 200/6 µg NEXThaler Versus CHF 1535 100/6 µg NEXThaler in Partially Controlled and Uncontrolled Adult Asthmatic Patients.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- FEV1 Area under the curve
研究概览
简要总结
The aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535 NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's written informed consent obtained prior to any study-related procedures.
- •Male or female aged between 18 and 65 years inclusive;
- •Evidence for "partially controlled" or "uncontrolled" asthma;
- •Medium daily dose of previous inhaled corticosteroids (ICS) treatment;
- •FEV1 between 60% and 85% of the predicted normal values;
- •A documented positive response to the reversibility test;
- •Non-smokers or ex-smokers;
- •A cooperative attitude and ability to be trained in the proper use of a DPI.
排除标准
- •Pregnant or lactating women and all women physiologically capable of becoming pregnant not willing to use at least one acceptable method of contraception.
- •Significant seasonal variation in asthma occurring or expected to occur during study participation;
- •History of near fatal asthma, brittle asthma, accident and Emergency treatment or hospitalisation for asthma exacerbation in Intensive Care Unit within 1 year before screening;
- •Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening;
- •Diagnosis of Chronic Obstructive Pulmonary Disease;
- •History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency;
- •Diagnosis of restrictive lung disease;
- •Patients treated with oral or parenteral corticosteroids in the previous 8 weeks;
- •Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids;
- •Allergy, sensitivity or intolerance to study drugs or excipients;
- •Patients who received any investigational drug within the last 8 weeks before the screening;
- •Patients taking any of the non-permitted concomitant medication;
- •Subjects unlikely to comply with the study protocol;
- •Any clinically relevant abnormal value or physical finding at screening;
- •Significant medical history;
- •Abnormal and clinically significant 12-lead electrocardiogram;
- •Patients with low compliance of QVAR intake.
研究组 & 干预措施
CHF1535 NEXThaler 100/6, 1 puff
Active Comparator
Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg
干预措施: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg (Drug)
CHF1535 NEXThaler 100/6 µg, 4 puffs
Active Comparator
Beclometasone Dipropionate 400 µg + Formoterol Fumarate 24 µg
干预措施: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg (Drug)
CHF1535 NEXThaler 200/6 µg, 1 puff
Experimental
Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg
干预措施: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg (Drug)
CHF1535 NEXThaler 200/6 µg, 4 puffs
Experimental
Beclometasone Dipropionate 800 µg + Formoterol Fumarate 24 µg
干预措施: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg (Drug)
Placebo NEXThaler
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
FEV1 Area under the curve
时间窗: until 12 h post dose
FEV1= Forced expiratory volume in the first second of expiration
次要结局
- FEV1 peak(until 12 h post dose)
- FVC area under the curve(until 12 h post dose)
- FVC peak(until 12 h post dose)
- Adverse events(over a period of 5 to 14 weeks)
研究者
研究点 (3)
Loading locations...
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