Kearns Nethmi, Williams Mathew, Bruce Pepa, Black Melissa, Kearns Ciléin, Sparks Jenny, Braithwaite Irene, Weatherall Mark, Beasley Richard
Medical Research Institute of New Zealand, Wellington, New Zealand
Medical Research Institute of New Zealand, Wellington, New Zealand.
Thorax. 2022 Jul 18. doi: 10.1136/thorax-2022-219052.
To compare bronchodilator response after to salbutamol and budesonide/formoterol in adults with stable asthma.
A double-blind, cross-over, single-centre, placebo-controlled, non-inferiority trial. Adults with stable asthma were randomised to different orders of two treatment regimens: two actuations of placebo via MDI and one actuation of budesonide/formoterol 200/6 µg via turbuhaler; and one actuation of placebo turbuhaler and two actuations of salbutamol 100 µg via MDI. The primary outcome measure was FEV after 2 min. Secondary outcome measures included FEV, mBorg Dyspnoea Scale score and visual analogue score for breathlessness over 30 min.
Forty-nine of 50 potential participants were randomised. One participant withdrew following the first intervention visit and another could not be randomised due to COVID-19 restrictions. The mean (SD) change from baseline FEV 2 min after treatment administration for budesonide/formoterol and salbutamol was 0.08 (0.14) L, n=49, and 0.17 (0.18) L, n=48, respectively, mean (95% CI) paired difference of -0.097 L (-0.147 to -0.047), p=0.07, against a non-inferiority bound of -0.06 L. In the secondary analysis, FEV over 30 min was lower for budesonide/formoterol compared with salbutamol, difference (95% CI): -0.10 (-0.12 to -0.08) L, p<0.001. There were no differences in Visual Analogue Scale score or mBorg Dyspnoea Scale score between treatments.
The results do not support the primary hypothesis of non-inferiority at the boundary of -0.06 L for the difference between budesonide/formoterol 200/6 µg compared with salbutamol 200 µg for FEV at 2 min, and could be consistent with inferiority with a p value of 0.07. For the secondary analysis of FEV measurements over time, the FEV was higher with salbutamol.
Australian and New Zealand Clinical Trials Registry (ACTRN 12619001387112).
比较沙丁胺醇与布地奈德/福莫特罗对稳定期哮喘成人的支气管扩张反应。
一项双盲、交叉、单中心、安慰剂对照的非劣效性试验。稳定期哮喘成人被随机分配到两种治疗方案的不同顺序：通过定量吸入器吸入两次安慰剂，以及通过都保吸入一次200/6 μg布地奈德/福莫特罗；以及通过都保吸入一次安慰剂，和通过定量吸入器吸入两次100 μg沙丁胺醇。主要结局指标是2分钟后的第一秒用力呼气量（FEV）。次要结局指标包括30分钟内的FEV、改良版博格呼吸困难量表评分和呼吸困难视觉模拟评分。
50名潜在参与者中有49名被随机分组。一名参与者在第一次干预访视后退出，另一名因COVID-19限制未能被随机分组。布地奈德/福莫特罗和沙丁胺醇给药后2分钟，FEV相对于基线的平均（标准差）变化分别为0.08（0.14）L，n = 49，和0.17（0.18）L，n = 48，平均（95%可信区间）配对差异为-0.097 L（-0.147至-0.047），p = 0.07，非劣效界值为-0.06 L。在次要分析中，布地奈德/福莫特罗组30分钟内的FEV低于沙丁胺醇组，差异（95%可信区间）：-0.10（-0.12至-0.08）L，p<0.001。各治疗组之间的视觉模拟评分或改良版博格呼吸困难量表评分无差异。
结果不支持布地奈德/福莫特罗200/6 μg与沙丁胺醇200 μg在2分钟时FEV差异的非劣效性主要假设，p值为0.07，可能提示布地奈德/福莫特罗较差。对于FEV随时间变化的次要分析，沙丁胺醇组的FEV更高。
澳大利亚和新西兰临床试验注册中心（ACTRN 12619001387112）。
