EUCTR2012-001172-12-ES进行中（未招募）不适用
A randomized, double-blind, 12-week treatment, parallel-group study to evaluate the efficacy and safety of QMF149 (150 µg/160 µg o.d.) compared with salmeterol xinafoate/fluticasone propionate (50 µg/500 µg b.i.d.) in patients with chronic obstructive pulmonary disease (COPD)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 576
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients with moderate to very severe COPD (GOLD 2 to GOLD 4) according to the 2011 GOLD Guidelines
- •2. Patients with a post-bronchodilator FEV1 < 70% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at run-in (Visit 101).
- •3. Current or ex-smokers who have a smoking history of at least 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked. e.g.10 pack years = 1 pack /day x 10 yrs, or
- •½ pack/day x 20 yrs). An ex-smoker may be defined as a subject who has not smoked for >= 6 months at screening.
- •*Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 576
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. Patients who have had a COPD exacerbation that required treatment
- •with antibiotics and/or oral corticosteroids and/or hospitalization in the
- •6 weeks prior to screening (Visit 1).
- •2. Patients who develop a COPD exacerbation between screening (Visit
- •1) and treatment (Visit 201) will not be eligible but will be permitted to
- •be re-screened after a minimum of 6 weeks after the resolution of the
- •COPD exacerbation.
- •3. Patients who have had a respiratory tract infection within 4 weeks
- •prior to screening Visit 1.
- •4. Patients who develop a respiratory tract infection between screening
- •(Visit 1) and treatment (Visit 201) will not be eligible, but will be
- •permitted to be rescreened 4 weeks after the resolution of the
- •respiratory tract infection.
- •5. Patients requiring long term oxygen therapy prescribed for >12 hours
- •6. Patients with, a) any history of asthma or, b) onset of respiratory
- •symptoms prior to age 40 years.
- •*Other protocol-defined exclusion criteria may apply
研究者
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