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The efficacy of aclidinium/formoterol on lung function and symptoms in patients with COPD categorized by symptom status: a pooled analysis

机译:沙丁胺醇/福莫特罗对按症状状态分类的COPD患者肺功能和症状的疗效:汇总分析

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Background: Patients with chronic obstructive pulmonary disease (COPD) experience respiratory symptoms, which impair quality of life. This pooled analysis of two Phase III studies assessed the impact of aclidinium/formoterol on patients with COPD categorized by symptom status. Methods: Data were pooled from two 24-week, randomized, placebo-controlled studies of twice-daily aclidinium/formoterol 400/12 μg in moderate-to-severe COPD (ACLIFORM [NCT01462942] and AUGMENT [NCT01437397]). These post hoc analyses evaluated the efficacy of aclidinium/formoterol versus placebo or monotherapies in patients defined as less/more symptomatic by a) Evaluating Respiratory Symptoms (E-RS?) score ≥10/1), Transition Dyspnea Index, E-RS total score, early-morning and nighttime symptom severity, early-morning limitation of activities, and exacerbation rate. Results: Data for 3,394 patients were analyzed (mean age: 63.5 years; 60.5% male). In both definitions of less and more symptomatic patients, aclidinium/formoterol improved 1-hour morning postdose FEV1 from baseline at week 24 versus placebo ( P 1 from baseline in both groups versus placebo ( P 1, dyspnea, and early-morning symptoms.
机译:背景:患有慢性阻塞性肺疾病(COPD)的患者会出现呼吸道症状,从而影响生活质量。这项对两项三期研究的汇总分析评估了按症状状态分类的阿地丁/福莫特罗对COPD患者的影响。方法:数据来自两项针对中重度COPD的每日两次阿地丁/福莫特罗400/12μg(ACLIFORM [NCT01462942]和AUGMENT [NCT01437397])的两项为期24周的随机,安慰剂对照研究。这些事后分析通过a)评估呼吸道症状(E-RS?)得分≥10/ 1 ),过渡型呼吸困难指数,阿司匹林/福莫特罗与安慰剂或单一疗法对被定义为症状更少/更多的患者的疗效进行了评估。 E-RS总分,早晨和夜间症状的严重程度,早晨的活动限制以及病情加重。结果:分析了3,394例患者的数据(平均年龄:63.5岁; 60.5%男性)。在越来越少有症状的患者的两种定义中,与安慰剂相比,阿曲丁铵/福莫特罗在用药后第1周早晨FEV 1 较基线改善了(两组与安慰剂相比,基线均P 1 ( P 1 ,呼吸困难和早起症状。

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