A 12-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Mild to Moderate Persistent Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 286
- 主要终点
- Pre-dose morning PEF
研究概览
简要总结
Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in patients with mild to moderate persistent asthma.
详细描述
The purpose of this study is to evaluate the efficacy and tolerability of Beclomethasone Dipropionate/Formoterol single inhaler in a twice daily regimen in patients with mild to moderate persistent asthma. Patients are randomised to receive either Beclomethasone Dipropionate/ formoterol single inhaler (total daily dose : BDP/FF 400/24 µg) or Beclomethasone CFC (total daily dose : BDP 1000 µg) during 12 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of mild to moderate persistent asthma (according to GINA 2003 guidelines)
- •FEV1 > or = 60% and < or = 85% of predicted normal values
- •Patients free of LABA at least for one month before screening and already treated for at least two months with ICS and experiencing (i)a daily use of SABAs between 1 and 4 puffs, (ii) and/or clinical symptoms three times in the week prior to inclusion
- •A documented positive response to the reversibility test
排除标准
- •Pregnant or lactating females or women of childbearing potential without any efficient contraception
- •Heavy smokers defined as smoking for > 10 pack years
- •Evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids)
- •Seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer
- •Clinical significant or unstable concomitant diseases, including clinically significant laboratory abnormalities
- •Evidence of asthma worsening during the week preceding randomisation (e.g PEF variability > or = 30% during 2 consecutive days, SABA use > 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days
研究组 & 干预措施
CHF 1535 pMDI
CHF 1535 HFA pMDI aerosol (100 µg/unit dose of beclomethasone dipropionate plus 6 µg of formoterol/unit dose
干预措施: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI (Drug)
BDP pMDI
Beclomethasone dipropionate-CFC pMDI, 250 µg/unit dose
干预措施: Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI (Drug)
结局指标
主要结局
Pre-dose morning PEF
时间窗: At the end of treatment after 3 month of treatment
次要结局
- Pre-dose FEV1 - Other spirometric parameters -(Every 6 weeks)
- Use of rescue short-acting b2-agonists(End of treatment after 3 month of treatment)
- Percentage of night and/or days free of clinical symptoms(End of treatment after 3 month of treatment)
- Asthma exacerbations(Every 6 weeks)
- Safety and Tolerability(Every 6 weeks)
- Morning and evening asthma clinical symptom scores(End of treatment after 3 month of treatment)