Effectiveness and quality of life in asthmatic patients treated with budesonide/formoterol via Elpenhaler® device in primary care. The “SKIRON” real world study

<b>Aim:</b> Inhaled corticosteroid (ICS)/long-acting β₂ agonist (LABA) combination therapy is used for the effective control of asthma. Aim of this study was to collect data on the effectiveness, safety, quality of life, and patient satisfaction from a fixed dose combination of budesonide/formoterol administered with the Elpenhaler^® device following 3-months’ treatment.<b>Methods:</b> A 3-month real-life, multicentre, one-arm, prospective observational study (SKIRON study-NCT03055793) was conducted, using the following questionnaires: Asthma Control Questionnaire (ACQ-6) for asthma control assessment, MiniAQLQ questionnaire for QoL assessment, and Feeling of Satisfaction with Inhaler questionnaire (FSI-10) for patients’ satisfaction with the inhaler device. Comorbidities and safety data were also recorded during the study.<b>Results:</b> We enrolled 1,174 asthmatic patients following standard clinical practice in primary care from 126 sites in urban and rural areas of Greece. The majority of patients (71.5%) had at least one comorbidity. A statistically significant improvement in the ACQ-6 score was noted at 3 months compared to the baseline evaluation (mean ± SD 2.19 ± 0.97 at baseline vs. 0.55 ± 0.56 at 3 months; mean change −1.64 (95%CI −1.69, −1.57), <i>p</i> &lt; 0.0001). MiniAQLQ score was statistically and clinically significantly improved, compared to baseline, (4.55 ± 1.04 at baseline vs. 6.37 ± 0.64 at 3 months; mean change 1.82 (95%CI 1.75, 1.87), <i>p</i> &lt; 0.0001). The mean FSI-10 score of 44.2 ± 5.4 indicated patient satisfaction and ease-of-use of the Elpenhaler^® device.<b>Conclusions:</b> In this large real-world study of inadequately-controlled asthma patients in primary care settings, the treatment with budesonide/formoterol FDC with the Elpenhaler^® device was associated with significant improvement in patients’ asthma control and quality of life.

**研究目的**：吸入性糖皮质激素（Inhaled Corticosteroid, ICS）/长效β₂受体激动剂（Long-acting β₂ Agonist, LABA）联合治疗可有效控制哮喘。本研究旨在收集采用Elpenhaler®装置给药的布地奈德/福莫特罗固定剂量复方制剂（Fixed Dose Combination, FDC），经3个月治疗后的有效性、安全性、生活质量及患者满意度相关数据。
**研究方法**：本研究为一项为期3个月的真实世界多中心单臂前瞻性观察性研究（SKIRON研究-NCT03055793），采用以下问卷开展评估：用于哮喘控制评估的哮喘控制问卷（Asthma Control Questionnaire, ACQ-6）、用于生活质量（Quality of Life, QoL）评估的MiniAQLQ问卷，以及用于评估患者对吸入装置满意度的吸入装置满意度问卷（Feeling of Satisfaction with Inhaler, FSI-10）。研究期间同步记录患者合并症与安全性数据。
**研究结果**：本研究从希腊城乡126个基层医疗临床中心招募了1174名遵循标准临床诊疗流程的哮喘患者。其中71.5%的患者存在至少1种合并症。与基线评估相比，3个月时的ACQ-6评分较基线存在统计学显著改善（基线时均值±标准差为2.19±0.97，3个月时为0.55±0.56；平均变化值为-1.64（95%置信区间[CI]：-1.69, -1.57），*p*<0.0001）。MiniAQLQ评分同样较基线存在统计学与临床意义上的显著改善（基线时为4.55±1.04，3个月时为6.37±0.64；平均变化值为1.82（95%CI：1.75, 1.87），*p*<0.0001）。患者的FSI-10平均评分为44.2±5.4，表明其对Elpenhaler®装置的满意度及易用性良好。
**研究结论**：在这项针对基层医疗环境中控制不佳的哮喘患者的大型真实世界研究中，采用Elpenhaler®装置给药的布地奈德/福莫特罗固定剂量复方制剂治疗，可显著改善患者的哮喘控制情况与生活质量。