A Phase 3,8-week Clinical Trial to Test the Efficacy of CHF1535 Via NEXT DPI® Versus Same Dose of CHF1535 pMDI and Beclomethasone DPI 100µg on PEF in Adult Asthmatic Patients After 1 Month of Treatment With FOSTER®
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 932
- 试验地点
- 1
- 主要终点
- Change from baseline to the entire treatment period in average pre-dose morning Peak Expiratory Flow.
研究概览
简要总结
The purpose of this study is to demonstrate that CHF 1535 NEXT DPI® is non-inferior to the corresponding dose of CHF 1535 pMDI and superior to marketed beclomethasone DPI 100 µg in terms of average pre-dose morning Peak Expiratory Flow (PEF) in asthmatic adult patients.
详细描述
The primary objective is to demonstrate that CHF 1535 NEXT DPI® (beclomethasone dipropionate + formoterol fumarate 100/6 μg), 1 inhalation twice daily, is non-inferior to the corresponding dose of CHF 1535 pMDI in terms of pulmonary function test (change from baseline to the entire treatment period in average pre-dose morning PEF) in asthmatic adult patients ≥ 18 years under treatment with fixed dose combination of Foster® (beclomethasone dipropionate + formoterol fumarate 100 / 6 μg) 1 inhalation bid.
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
- 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
- •Male and female adults (≥18 years old).
- •Reversibility test defined as ΔFEV1 ≥ 12% and ≥ 200 mL .
- •FEV1 > 80% of the predicted values .
- •Asthma Control Questionnaire score < 1.
- •Asthmatic patients
- •Non- or ex-smokers
排除标准
- •History of near fatal asthma.
- •COPD patients
- •Asthma exacerbation within 1 month prior to the screening visit or asthma exacerbation during the run-in period.
- •Lower respiratory tract infection within 1 month prior Visit1 (V1).
- •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 2 months before V1
- •Intolerance or contra-indication to treatment with beta 2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments.
- •Significant medical history of and/or treatments
- •Active cancer or a history of cancer .
研究组 & 干预措施
CHF 1535 100/6 NEXT Dry Powder Inhaler®
CHF1535 100/6 NEXT DPI® 1 inhalation bis in day (b.i.d) (daily dose BDP 200/FF 12 µg)
干预措施: CHF 1535 100/6 NEXT DPI® 2 months (Drug)
CHF1535 100/6 pMDI
CHF1535 100/6 pressurisedMeterDoseInhaler 1 inhalation b.i.d (total daily dose BDP 200/FF 12 µg)
干预措施: CHF 1535 100/6 pMDI 2 months (Drug)
beclomethasone dipropionate DPI
beclomethasone dipropionate 100 µg DPI, 1 inhalation b.i.d (total daily dose BDP 200 µg)
干预措施: BDP DPI 2 months (Drug)
结局指标
主要结局
Change from baseline to the entire treatment period in average pre-dose morning Peak Expiratory Flow.
时间窗: at 8 weeks
次要结局
- Pre-dose morning FEV1 (Forced Expiratory Volume in one second);(at 2, 4, 6 and 8 weeks of treatment)
- Pre-dose morning FVC (Force Vital Capacity) ;(at 2, 4, 6 and 8 weeks of treatment)
- ACQ (Asthma Control Questionnaire) score ;(at eight weeks)
- pre-dose evening PEF ;(at 2, 4, 6 and 8 weeks of treatment)
- daily PEF variability ;(at 2, 4, 6 and 8 weeks of treatment)
- use of rescue medication ;(at 2, 4, 6 and 8 weeks of treatment)
- percentage of rescue use-free days(at 2, 4, 6 and 8 weeks of treatment)
- pre-dose morning PEF ;(at 2, 4, 6 and 8 weeks of treatment)