Medical Research Institute of New Zealand, Wellington, New Zealand
Medical Research Institute of New Zealand, Wellington, New Zealand.
BMJ Open Respir Res. 2022 Aug;9(1). doi: 10.1136/bmjresp-2022-001271.
In randomised controlled trials, as-needed inhaled corticosteroid (ICS)-formoterol reliever therapy reduces severe exacerbation risk compared with maintenance ICS plus short-acting beta-agonist (SABA) reliever in adolescent and adult asthma, but results in slightly worse control of asthma symptoms, as measured by mean Asthma Control Questionnaire-5 (ACQ-5) score.
To assess the levels and changes in asthma control for as-needed budesonide-formoterol versus maintenance budesonide plus SABA in post hoc analyses from the Novel START and PRACTICAL clinical trials.
The number and proportion of participants at study end in each ACQ-5 category ('well-controlled', 'partly controlled' or 'inadequately controlled' symptoms), and in each responder category based on the minimal clinically important difference for ACQ-5 of 0.5 (improved, no change and worse) with as-needed budesonide-formoterol and maintenance budesonide plus SABA treatment were calculated.
With last observation carried forwards, 189/214 (88.3%) and 354/434 (81.6%) of patients in the budesonide-formoterol group had 'well-controlled' or 'partly controlled' symptoms at the end of the study, vs 183/214 (85.5%) and 358/431 (83.1%) in the budesonide maintenance group, for Novel START and PRACTICAL, respectively. The proportion of patients whose symptom control was either improved or unchanged from baseline was 190/214 (88.8%) and 368/434 (84.8%) for budesonide-formoterol, vs 185/214 (86.4%) and 376/431 (87.2%) for maintenance budesonide, in Novel START and PRACTICAL respectively.
There were no clinically important differences in the proportions of patients with 'well-controlled' or 'partly controlled' asthma symptoms, or proportions who improved or maintained their level of control, with as-needed budesonide-formoterol versus maintenance budesonide plus SABA.
在随机对照试验中，按需吸入皮质类固醇（ICS）-福莫特罗缓解治疗与维持 ICS 加短效β-激动剂（SABA）缓解治疗相比，可降低青少年和成年哮喘患者的严重恶化风险，但哮喘症状的控制略有恶化，这是通过平均哮喘控制问卷-5（ACQ-5）评分来衡量的。
在 Novel START 和 PRACTICAL 临床试验的事后分析中，评估按需布地奈德-福莫特罗与维持布地奈德加 SABA 治疗的哮喘控制水平和变化。
根据 ACQ-5 最小临床重要差异（0.5），计算在每个 ACQ-5 类别（“控制良好”、“部分控制”或“控制不佳”症状）结束时使用按需布地奈德-福莫特罗和维持布地奈德加 SABA 治疗的参与者人数和比例，以及基于 ACQ-5 改善、无变化和恶化的每个反应者类别。
在最后一次观察结果推进的情况下，在 Novel START 和 PRACTICAL 中，按需布地奈德-福莫特罗组分别有 189/214（88.3%）和 354/434（81.6%）的患者在研究结束时具有“控制良好”或“部分控制”症状，而在维持布地奈德组中，分别有 183/214（85.5%）和 358/431（83.1%）的患者在研究结束时具有“控制良好”或“部分控制”症状。在 Novel START 和 PRACTICAL 中，与基线相比，症状控制得到改善或无变化的患者比例分别为 190/214（88.8%）和 368/434（84.8%），而在维持布地奈德组中，分别为 185/214（86.4%）和 376/431（87.2%）。
按需布地奈德-福莫特罗与维持布地奈德加 SABA 相比，在“控制良好”或“部分控制”哮喘症状的患者比例或改善或维持其控制水平的患者比例方面没有临床意义上的差异。
