A 24-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Moderate to Severe Persistent Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 824
- 主要终点
- Pre-dose morning PEF
研究概览
简要总结
Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.
详细描述
The purpose of this study is to evaluate the efficacy and tolerability of beclometasone/formoterol single inhaler in a twice daily regimen in patients with moderate to severe persistent asthma. Patients are randomised to receive either beclometasone/formoterol single inhaler (total daily dose: BDP/FF 400/24 mcg) or beclometasone CFC + formoterol DPI (total daily dose: BDP 1000 mcg + FF 24 mcg) or beclometasone CFC (total daily dose: BDP 1000 mcg) during 24 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
- 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 moderate to severe persistent asthma (according to GINA 2002 guidelines)
- •FEV1 > 40% and < 80% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)
- •Patients already treated for at least 2 months with an association of inhaled corticosteroids plus LABA at doses of:
- •750 - 1000 µg beclomethasone dipropionate or equivalent (ICSs) 24 µg formoterol or 100 µg salmeterol (LABAs)
- •Or patients naïve of LABA already treated for at least 2 months with inhaled corticosteroids (doses as above) associated with a daily use of SABA and/or with clinical symptoms > 3 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.
- •Clinically significant or unstable concomitant diseases, including clinically significant laboratory abnormalities.
- •Patients with an abnormal QTc interval value in the ECG test, defined as > 450 msec in males or > 470 msec in females.
- •Evidence of asthma worsening during the week preceding randomisation (e.g. PEF variability > 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
Beclomethasone
Beclomethasone dipropionate (BecotideTM) 250 µg/unit dose pMDI aerosol via CFC propellant.
干预措施: Beclometasone dipropionate 250 µg/unit dose pMDI (Drug)
beclometasone /formoterol
beclomethasone dipropionate 100 µg plus formoterol 6 µg pMDI
干预措施: beclomethasone/formoterol (100/6µg) pMDI (Drug)
Formoterol powder 12 µg/unit dose
Formoterol powder 12 µg/unit dose (Foradil™)
干预措施: Formoterol powder 12 µg/unit dose (Drug)
结局指标
主要结局
Pre-dose morning PEF
时间窗: End of treatment
次要结局
- Other spirometric parameters(At clinic visits)
- Use of rescue short-acting b2-agonists(End of treatment)
- Pre-dose FEV1(At clinic visits)
- Asthma exacerbations(end of treatment)
- safety and tolerability(end of treatment)
- Morning and evening asthma clinical symptom scores(End of treatment)
- Percentage of night and/or days free of clinical symptoms(End of treatment)