Fysikalisk Medicin i Stockholm AB, Lidingö, Sweden.
Academic Primary Health Care Centre, Stockholm, Sweden.
Ther Adv Respir Dis. 2021 Jan-Dec;15:17534666211027787. doi: 10.1177/17534666211027787.
Selection of the most appropriate device for a switch from one inhaler to an equivalent product is known to have a major impact on clinical outcomes in patients with asthma or chronic obstructive pulmonary disease (COPD). Salmeterol/fluticasone propionate (S/F) Easyhaler has been demonstrated to be therapeutically equivalent with a reference product. However, no data on real-life effectiveness are currently available for patients switching to S/F Easyhaler from another S/F inhaler.
The aim of this prospective, open, multicenter, non-interventional study was to assess clinical effectiveness of propionate S/F Easyhaler in adult asthma and COPD patients switched from another inhaler. The primary endpoints were Asthma Control Test (ACT) and COPD Assessment Test (CAT). Secondary endpoints included assessments of patient satisfaction and preference and physician/nurse perception on S/F Easyhaler use. The study included three visits during a 12-week follow-up.
A total of 211 patients (160 with asthma; 51 with COPD) were included in the analyses. In patients with asthma, there was a statistically significant increase in the mean ACT score at week 12 (20.2 ± 3.9) compared with the baseline (18.6 ± 4.1), with a mean increase of 1.6 (±3.5) points ( < 0.0001). In patients with COPD, CAT score persisted from baseline (19.9 ± 8.6) to week 12 (19.6 ± 7.0). Patients were significantly more satisfied with Easyhaler and most patients preferred Easyhaler over their previous inhaler. The physicians/nurses reported that it was 'very easy' to teach the use of Easyhaler and the training took less than 5 minutes in most cases.
The results from this prospective real-life clinical study indicate better or at least similar treatment control of asthma and COPD after switching to S/F Easyhaler from another S/F inhaler. This study also shows that S/F Easyhaler was favored by the patients and that it is easy to teach, learn and use in a real-life setting.
对于哮喘或慢性阻塞性肺疾病(COPD)患者,从一种吸入器切换到等效产品时,选择最合适的设备对临床结果有重大影响。沙美特罗/氟替卡松丙酸酯(S/F)易纳器已被证明在治疗上与参比产品等效。然而,目前尚无患者从另一种 S/F 吸入器切换到 S/F 易纳器后的实际疗效数据。
这项前瞻性、开放、多中心、非干预性研究的目的是评估丙酸 S/F 易纳器在从另一种吸入器转换的成年哮喘和 COPD 患者中的临床疗效。主要终点是哮喘控制测试(ACT)和 COPD 评估测试(CAT)。次要终点包括对患者满意度和偏好的评估,以及医生/护士对 S/F 易纳器使用的看法。该研究包括在 12 周随访期间进行三次访视。
共纳入 211 名患者(哮喘 160 例;COPD 51 例)进行分析。在哮喘患者中,第 12 周的平均 ACT 评分(20.2±3.9)与基线相比有统计学显著增加(18.6±4.1),平均增加 1.6(±3.5)分( < 0.0001)。在 COPD 患者中,CAT 评分从基线(19.9±8.6)到第 12 周(19.6±7.0)保持不变。患者对易纳器的满意度显著提高,大多数患者更喜欢易纳器而不是他们以前的吸入器。医生/护士报告说,易纳器的使用非常容易教授,而且在大多数情况下,培训时间不到 5 分钟。
这项前瞻性真实临床研究的结果表明,从另一种 S/F 吸入器转换到 S/F 易纳器后,哮喘和 COPD 的治疗控制得到了改善或至少相似。这项研究还表明,S/F 易纳器受到患者的青睐,并且易于在真实环境中教授、学习和使用。