NCT00868023已完成2 期
A Phase II, Multinational, Multicentre, Double Blind, Double Dummy, Randomised, 5-way Cross-over, Placebo and Active Controlled Clinical Study to Test the Non-inferiority of a Single Dose of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg Dry Powder) Via NEXT™ DPI 1 or 4 Inhalations Versus CHF 1535 (Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg) pMDI With HFA-134a Propellant 1 or 4 Puffs on FEV1 AUC0-12h in Partly Controlled Adult Asthmatic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- FEV1 AUC0-12h
研究概览
简要总结
Multinational, multicentre, randomised, double blind, double dummy, placebo and active controlled, 5-way cross over
详细描述
To demonstrate the non-inferiority in terms of FEV1 AUC0-12h between a single dose of CHF 1535 via NEXT DPI and CHF 1535 via HFA-134a "extrafine" pMDI in partly controlled adult 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
- Double (Participant, Investigator)
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
- •Patient's written informed consent obtained prior to any study-related procedures.
- •Outpatient male or female aged ≥ 18 years.
- •Evidence for "partly controlled" asthma in the 2 weeks before the screening visit
- •Under previous inhaled corticosteroids (ICS) treatment at the screening visit
- •Forced expiratory volume in the first second (FEV1) ≥ 60% and ≤ 90% of the predicted normal values at the screening visit.
- •A documented positive response to the reversibility test at the screening visit, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, 30 minutes after 400 μg salbutamol pMDI
- •Patients free of long-acting beta2-agonists (LABAs) treatment for at least 2 weeks before the screening visit.
- •Patients free of short-acting beta2-agonists (SABAs) treatment for at least 6 hours before the screening visit.
- •Non-smokers or ex-smokers
排除标准
- •Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they are menopausal or are using effective and acceptable methods of contraception.
- •Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
- •History of near fatal asthma (e.g. brittle asthma, 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 visit.
- •Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- •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 (12 weeks for parenteral depot corticosteroids) before screening visit.
- •Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids.
- •Allergy, sensitivity or intolerance to study drugs or excipients.
- •Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality.
研究组 & 干预措施
1
Experimental
CHF 1535 DPI : BDP/Formo 400/24 µg
干预措施: CHF 1535 Next DPI (Drug)
2
Active Comparator
CHF 1535 pMDI HFA : BDP/Formo 400/24 µg
干预措施: Foster BDP/Formoterol (Drug)
3
Experimental
CHF 1535 DPI : BDP/Formo 100/6 µg
干预措施: CHF 1535 Next DPI (Drug)
4
Active Comparator
CHF 1535 pMDI HFA : BDP/Formo 100/6 µg
干预措施: Foster BDP/Formoterol (Drug)
5
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
FEV1 AUC0-12h
时间窗: Every week
次要结局
- FVC as assessed at the same time points as for FEV1; Peak FEV1 in terms of absolute values and % of change from baseline Safety evaluation(Every week)
研究者
研究点 (1)
Loading locations...
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