Department of Allergology and Pulmonology, Postgraduate Centre for Medical Education, Warsaw, Poland.
Medical Affairs, Orion Pharma Poland Co. Ltd, Warsaw, Poland.
Adv Ther. 2017 Dec;34(12):2648-2660. doi: 10.1007/s12325-017-0641-5. Epub 2017 Nov 8.
The effectiveness of single-inhaler budesonide/formoterol fumarate combination therapy for asthma has been previously shown for the original product. The aim of this nonrandomized, open-label, postauthorization efficacy study (PAES) real-life clinical assessment was to evaluate the clinical effectiveness of a second product (Bufomix Easyhaler) in the daily clinical practice of asthma therapy.
This multicenter PAES was conducted by 220 unselected allergologists and pulmonologists who enrolled 2200 adult outpatients (age 49.8 ± 17.9 years) with asthma treated with Bufomix Easyhaler for at least 14 days before enrolment. Asthma control was assessed during three subsequent visits with 8-12-week intervals on the basis of the Asthma Control Test (ACT). Adherence was assessed with the Medication Adherence Questionnaire. In addition, patient satisfaction with Bufomix Easyhaler was scored, and adverse drug reactions were recorded.
The percentage of patients with well-controlled asthma or total control of asthma (ACT score 20-25 points) increased from 46.6% at the first visit to 90.8% at the third visit (p < 0.001). In addition, the percentage of patients with poor control of asthma (ACT score less than 15 points) decreased from 14.9% to 1.2% (p < 0.001). The adherence rate increased from 88% at the first visit to 95.3% at the third visit. Patient satisfaction with the use of this dry powder inhaler increased with the duration of its use. Only one adverse drug reaction was reported.
The results obtained confirm the effectiveness of Bufomix Easyhaler in the treatment of asthma in outpatient adults in daily clinical practice.
Orion Corporation.
布地奈德/福莫特罗富马酸盐单一吸入剂联合疗法对哮喘的有效性已在原产品中得到证实。本非随机、开放性、上市后疗效研究（PAES）真实临床评估的目的是评估第二种产品（布福莫特罗 Easyhaler）在哮喘治疗日常临床实践中的临床疗效。
本多中心 PAES 由 220 名未经选择的过敏症专家和肺病专家进行，他们招募了 2200 名成年门诊患者（年龄 49.8±17.9 岁），这些患者在入组前至少使用布福莫特罗 Easyhaler 治疗 14 天。哮喘控制在随后的三次就诊中进行评估，间隔 8-12 周，基于哮喘控制测试（ACT）。使用药物依从性问卷评估依从性。此外，还对患者对布福莫特罗 Easyhaler 的满意度进行了评分，并记录了药物不良反应。
在第一次就诊时，有良好控制或完全控制哮喘（ACT 评分 20-25 分）的患者比例从 46.6%增加到第三次就诊时的 90.8%（p<0.001）。此外，哮喘控制不佳（ACT 评分低于 15 分）的患者比例从 14.9%降至 1.2%（p<0.001）。第一次就诊时的依从率从 88%增加到第三次就诊时的 95.3%。随着使用时间的延长，患者对使用这种干粉吸入器的满意度增加。仅报告了一例药物不良反应。
研究结果证实了布福莫特罗 Easyhaler 在日常临床实践中治疗门诊成年哮喘患者的有效性。
Orion 公司。
