Kreiskliniken Reutlingen/Ermstalklinik, Reutlingen-Bad Urach, Germany,
POIS Leipzig GbR, Gessner & Gessner, Leipzig, Germany.
Respiration. 2019;97(4):292-301. doi: 10.1159/000493860. Epub 2018 Nov 2.
BACKGROUND: The fixed-dose combination of budesonide/formoterol (B/F) has been available in the Spiromax® dry powder inhaler since 2014. OBJECTIVES: To assess patient satisfaction, inhaler use errors, and disease control in patients with asthma or chronic obstructive pulmonary disease (COPD) treated with B/F Spiromax. METHODS: This non-interventional, prospective, 12-week study enrolled consecutive asthma or COPD patients who had recently begun treatment with B/F Spiromax or were switched from another inhaled corticosteroid/long-acting β2-agonist combination to B/F Spiromax in routine clinical practice. Patients recruited from 243 specialist respiratory clinics or general practices in Germany were assessed for patient satisfaction (Satisfaction with Inhalers and Preference questionnaire), inhaler application errors (modified Easy Low Instruction over Time checklist), disease control, and safety. RESULTS: The population included 3,943 patients: asthma n = 2,707 (68.7%); COPD n = 1,236 (31.3%). At baseline, 60.1% of patients were "satisfied" or "very satisfied" with their previous inhaler, and this increased to 88.8% at week 12 of B/F Spiromax use. Overall, 62.1% of pre-treated patients preferred B/F Spiromax to their old inhaler. The frequency of any handling error observed with B/F Spiromax at week 12 was lower than at baseline (11.9 vs. 25.5% of patients, respectively). After 12 weeks, 77.4% were assessed as having improved (minimally, much, or very much) overall health status versus baseline. Guideline-defined disease severity (as rated by physicians) and patient-reported symptom severity improved during the study in both asthma and COPD patients. B/F Spiromax was well tolerated. CONCLUSION: B/F Spiromax was associated with high patient satisfaction, low device handling error rate, and improvements in clinical outcomes in real-world clinical practice.
背景:自 2014 年以来,布地奈德/福莫特罗(B/F)固定剂量组合已在 Spiromax®干粉吸入器中使用。
目的:评估哮喘或慢性阻塞性肺疾病(COPD)患者使用布地奈德/福莫特罗 Spiromax 治疗后的患者满意度、吸入器使用错误和疾病控制情况。
方法:这项非干预性、前瞻性、为期 12 周的研究纳入了最近开始接受布地奈德/福莫特罗 Spiromax 治疗或从其他吸入性皮质类固醇/长效β2-激动剂联合药物转换为布地奈德/福莫特罗 Spiromax 的连续哮喘或 COPD 患者。在德国的 243 家专科呼吸诊所或普通诊所招募的患者接受了患者满意度(吸入器满意度和偏好问卷)、吸入器应用错误(改良的随时间推移的简单低指令清单)、疾病控制和安全性评估。
结果:该人群包括 3943 名患者:哮喘 n = 2707(68.7%);COPD n = 1236(31.3%)。在基线时,60.1%的患者对之前使用的吸入器“满意”或“非常满意”,在使用布地奈德/福莫特罗 Spiromax 的第 12 周增加到 88.8%。总体而言,62.1%的预处理患者更喜欢布地奈德/福莫特罗 Spiromax 而非其旧吸入器。在第 12 周,使用布地奈德/福莫特罗 Spiromax 观察到的任何处理错误的频率低于基线时(分别为 11.9%和 25.5%的患者)。在 12 周后,与基线相比,77.4%的患者总体健康状况(轻度、中度或重度)得到改善。在哮喘和 COPD 患者中,指南定义的疾病严重程度(由医生评估)和患者报告的症状严重程度在研究期间均有所改善。布地奈德/福莫特罗 Spiromax 具有良好的耐受性。
结论:在真实世界的临床实践中,布地奈德/福莫特罗 Spiromax 与患者满意度高、设备处理错误率低以及临床结局改善有关。
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