EUCTR2012-001172-12-BE进行中（未招募）1 期
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
- 1 期
- 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
- •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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