A 48-week, Double Blind, Double Dummy, Randomised, Multinational, Multicentre, 3-arm Parallel Group Clinical Study of "Fixed Combination" Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI With HFA-134a Propellant Versus "Fixed Combination" Budesonide Plus Formoterol DPI Versus Formoterol DPI in Patients With Stable Severe Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 828
- 试验地点
- 1
- 主要终点
- Number of COPD exacerbations and pre-dose morning FEV1
研究概览
简要总结
To evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD.
详细描述
The purpose of this study is to evaluate the long-term efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD. Patients are randomised to receive either beclometasone/formoterol or budesonide/formoterol DPI or formoterol DPI during 48 weeks of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of COPD (according to GOLD guidelines)
- •FEV1 > or equal 30% and < 50% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)
- •COPD symptoms for at least 2 years
- •At least 1 exacerbation requiring medical intervention (oral corticosteroid and/or antibiotic treatment and/or need for a visit to an emergency department and/or hospitalization) within 2-12 months before screening
- •Current or previous smoker with a cumulative exposure to smoke of more than 20-pack year
排除标准
- •Current or past diagnosis of asthma, or any evidence suggestive of asthma
- •Positive FEV1 reversibility test
- •Clinically significant or unstable concurrent diseases, including clinically significant laboratory abnormalities
- •Acute COPD exacerbation or lower tract infection and/or treatment with oral or injectable corticosteroids and antibiotics in the 2 months before screening or during run-in
- •Long term oxygen therapy
研究组 & 干预措施
Budesonide 200 µg plus formoterol 6 µg DPI
干预措施: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI (Drug)
Budesonide 200 µg plus formoterol 6 µg DPI
干预措施: Budesonide 200 µg plus formoterol 6 µg DPI (Drug)
Budesonide 200 µg plus formoterol 6 µg DPI
干预措施: Formoterol 12 µg DPI (Drug)
Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
干预措施: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI (Drug)
Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
干预措施: Budesonide 200 µg plus formoterol 6 µg DPI (Drug)
Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
干预措施: Formoterol 12 µg DPI (Drug)
Formoterol 12 µg DPI
干预措施: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI (Drug)
Formoterol 12 µg DPI
干预措施: Budesonide 200 µg plus formoterol 6 µg DPI (Drug)
Formoterol 12 µg DPI
干预措施: Formoterol 12 µg DPI (Drug)
结局指标
主要结局
Number of COPD exacerbations and pre-dose morning FEV1
时间窗: one year treatment
次要结局
- COPD symptom scores and Quality of Life,(one year treatment)
- Other pulmonary function parameters,(one year treatment)
- safety and tolerability(one year treatment)