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Pragmatic evaluation of inhaled corticosteroid particle size formulations on asthma control

机译：吸入皮质类固醇粒径配方的语用评价哮喘控制

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Abstract Background Extra‐fine particle formulations of inhaled corticosteroid (ICS) are associated with improved lung delivery. Objectives A pragmatic study to assess patient‐reported outcomes after switching from fine to extra‐fine particle ICS in persistent asthma. Methods Twenty‐four patients (mean age 48?year, FEV 1 84%, ACQ 1.67) received 4?weeks run‐in with a constant dose of fine particle ICS (mean dose 710?μg), followed by switching to an equivalent dose of extra‐fine particle hydrofluoroalkane beclomethasone dipropionate (mean dose 355μg). Asthma control questionnaire (ACQ), the primary outcome and mini asthma quality of life questionnaire (mAQLQ) were measured pre‐ and post‐run‐in (baseline) and after 4?weeks and 8?weeks of switching. Results Comparing pre‐ vs post‐run‐in, there were no differences for ACQ: 1.67 vs 1.65 or AQLQ: 5.08 vs 5.34. There were mean (95%CI) improvements ( P ??0.001) from baseline after 8?weeks for ACQ: ?0.53 (?0.83, ?0.23) and AQLQ: 0.69 (0.35, 1.04), which exceeded the minimal clinically important difference (MCID) of 0.5 for both. There were also differences ( P ??0.05) in domiciliary symptoms and reliever use. There were no significant changes at 8?weeks in lung function, FeNO or blood eosinophils. Conclusions Pragmatic switching from fine to extra‐fine particle ICS at half the dose was associated with clinically relevant improvements in asthma control and quality of life, but not lung function or type 2 biomarkers.
机译：摘要背景中吸入皮质类固醇（IC）的超细粒子制剂与改善的肺递送有关。目的，务实的研究在从持久性哮喘中从良好到超细颗粒IC切换到切换后的患者报告的结果。方法二十四名患者（平均48岁以下，FEV 1 84％，ACQ 1.67）收到4？周的常数细粒子IC（平均剂量710≤μg），然后切换到等效剂量超细颗粒氢氟烷烃替代塞洛塞酮二双丙酸酯（平均剂量355μg）。哮喘控制调查问卷（ACQ），主要结果和迷你哮喘质量调查问卷（MAQLQ）被测量（基线）和4个周和8周后的转换后。结果比较续地前的预期预期，ACQ的差异无差异：1.67 VS 1.65或AQLQ：5.08 VS 5.34。在8℃的基线后，有平均值（95％CI）改善（p≤≤0.001）：Δ0.53（？0.83，β03）和aqlq：0.69（0.35,1.04），临床上超过最小值两者都有0.5的重要差异（MCID）。在住所症状和救济用力中也存在差异（p≤≤0.05）。肺功能，芬粮或血液粒细胞8周内没有显着变化。结论从一半剂量从良好到超细粒子IC的务实切换与哮喘控制和生活质量的临床相关改善有关，但不是肺功能或2种生物标志物。

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