Miravitlles Marc, Montero-Caballero Jéssica, Richard Frank, Santos Salud, Garcia-Rivero Juan Luis, Ortega Francisco, Ribera Xavier
Pneumology Department, Hospital Universitari Vall d'Hebron, Ciber de Enfermedades Respiratorias (CIBERES), Barcelona, Spain.
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.
Int J Chron Obstruct Pulmon Dis. 2016 Feb 26;11:407-15. doi: 10.2147/COPD.S91118. eCollection 2016.
Delivery of inhaled medications via an inhaler device underpins the effectiveness of treatment for patients with chronic obstructive pulmonary disease (COPD). Correct inhaler technique among patients is also a predictor of achieving treatment compliance and adherence. Reporting of patient satisfaction with inhalers is therefore gaining increasing attention and is now recognized as an important patient-reported outcome in clinical trials involving patients with COPD or asthma. In this cross-sectional study, we use the validated Patient Satisfaction and Preference Questionnaire (PASAPQ) to assess the handling and satisfaction for Respimat(®) Soft Mist™ Inhaler (SMI) compared with the Breezhaler(®) dry powder inhaler (DPI) among patients with COPD in Spain. Patients were already assigned to therapy with either SPIRIVA(®) (tiotropium) Respimat(®) or with Hirobriz(®)/Onbrez(®)/Oslif(®) (indacaterol) Breezhaler(®) for at least 3 but not more than 6 months before completing the PASAPQ at a single visit to the study site. The primary endpoint of the trial was the mean total PASAPQ score. Secondary endpoints were the performance score domain of the PASAPQ, the convenience score domain of the PASAPQ, and the overall satisfaction score of the PASAPQ. For the primary endpoint, the mean PASAPQ total score in the Respimat(®) and Breezhaler(®) groups was 80.7 and 79.9, respectively (difference of 0.8, 95% confidence interval [CI] -2.9 to 4.5; P=0.67). The mean total performance scores were 82.5 and 78.2 (difference of 4.3, 95% CI -0.3 to 8.9; P=0.06), and the mean total convenience scores were 78.6 and 81.9 (difference of -3.3, 95% CI -7.0 to 0.4; P=0.08) for the Respimat(®) and Breezhaler(®) groups, respectively. Patients gave the Respimat(®) SMI and the Breezhaler(®) DPI overall satisfaction PASAPQ scores of 6.0 and 5.9, respectively, which shows that patients were satisfied with these inhalers.
通过吸入装置递送吸入药物是慢性阻塞性肺疾病（COPD）患者治疗有效性的基础。患者正确的吸入技术也是实现治疗依从性和坚持性的一个预测指标。因此，患者对吸入器满意度的报告越来越受到关注，并且现在在涉及COPD或哮喘患者的临床试验中被视为一项重要的患者报告结局。在这项横断面研究中，我们使用经过验证的患者满意度和偏好问卷（PASAPQ），在西班牙的COPD患者中评估与都保（Breezhaler®）干粉吸入器（DPI）相比，能倍乐（Respimat®）软雾吸入器（SMI）的使用体验和满意度。在单次前往研究地点完成PASAPQ之前，患者已被分配使用思力华（SPIRIVA®）（噻托溴铵）能倍乐（Respimat®）或希润（Hirobriz®）/昂润（Onbrez®）/欧乐欣（Oslif®）（茚达特罗）都保（Breezhaler®）进行治疗至少3个月但不超过6个月。该试验的主要终点是PASAPQ的平均总分。次要终点是PASAPQ的性能评分领域、PASAPQ的便利性评分领域以及PASAPQ的总体满意度评分。对于主要终点，能倍乐（Respimat®）组和都保（Breezhaler®）组的PASAPQ平均总分分别为80.7和79.9（差异为0.8，95%置信区间[CI] -2.9至4.5；P = 0.67）。能倍乐（Respimat®）组和都保（Breezhaler®）组的平均总性能得分分别为82.5和78.2（差异为4.3，95% CI -0.3至8.9；P = 0.06），平均总便利性得分分别为78.6和81.9（差异为 -3.3，95% CI -7.0至0.4；P = 0.08）。患者对能倍乐（Respimat®）SMI和都保（Breezhaler®）DPI的PASAPQ总体满意度评分分别为6.0和5.9，这表明患者对这些吸入器感到满意。
