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>The TRIFLOW study: a randomised, cross-over study evaluating the effects of extrafine beclometasone/formoterol/glycopyrronium on gas trapping in COPD
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The TRIFLOW study: a randomised, cross-over study evaluating the effects of extrafine beclometasone/formoterol/glycopyrronium on gas trapping in COPD
Abstract Background The effects of triple therapy on gas trapping in COPD are not fully understood. We evaluated the effects of the long acting bronchodilator components of the extrafine single inhaler triple therapy beclometasone dipropionate/formoterol/glycopyrronium (BDP/F/G) pMDI on gas trapping. Methods This open-label, randomised, single centre, 2-way cross-over study recruited 23 COPD patients taking inhaled corticosteroid combination treatments and with residual volume (RV)??120% predicted at screening. Inhaled BDP was taken during run-in and washout periods. Baseline lung function (spirometry, lung volumes, oscillometry) was measured over 12?h prior to randomisation to BDP/F/G or BDP/F for 5?days followed by washout and crossover. Lung function was measured prior to dosing on day 1 and for 12?h post-dose on day 5. Results Co-primary endpoint analysis: BDP/F/G had a greater effect than BDP/F on FEV 1 area under the curve over 12?h (AUC 0–12 ) (mean difference 104 mls, p?=?0.0071) and RV AUC 0–12 (mean difference ??163 mls, p?=?0.0028). Oscillometry measurements showed a greater effect of BDP/F/G on the difference between resistance at 5 and 20?Hz (R5–R20) AUC 0–12 , which measures small airway resistance (mean difference ??0.045?kPa/L/s, p?=?0.0002). Comparison of BDP/F with the baseline measurements (BDP alone) showed that F increased FEV 1 AUC 0–12 (mean difference 227 mls) and improved RV AUC 0–12 (mean difference ??558 mls) and R5–R20 AUC 0–12 (mean difference ??0.117?kPa/L/s), all p??0.0001. Conclusions In COPD patients with hyperinflation, the G and F components of extrafine BDP/F/G improved FEV 1 , RV and small airway function. These long acting bronchodilators target small airway function, thereby improving gas trapping and airflow. Trial registration The study was retrospectively registered at ClinicalTrials.gov on 15th February 2019 (No.: NCT03842904, https://clinicaltrials.gov/ct2/show/NCT03842904 ).
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机译：摘要三重疗法对COPD气体捕获的影响尚未完全理解。我们评估了在气体捕获的气体捕获时，评估了预杂环型唯一吸入器三重疗法的长效支气管分子组分的效果二丙酸二维疗法BECLOMENONE双丙酸酯/甲酚/糖酮（BDP / F / G）PMDI。方法采用这种开放标签，随机，单中心，双向交叉研究招募了23名COPD患者吸入皮质类固醇组合治疗和残留体积（RV）？> 120％在筛选时预测。吸入的BDP在运行期和洗涤期间采取。在随机化之前测量基线肺功能（肺活量，肺体积，示波器），在随机化至BDP / F / G或BDP / F之前测量5？天，然后进行冲洗和交叉。在第5天和剂量后给药之前测量肺功能5.结果中的曲线上的CEV / F在曲线下的FEV 1面积上具有比BDP / F更大的效果在给药之前测量12？H（AUC 0-12）（平均差异104mL，p？= 0.0071）和RV AUC 0-12（平均差异为163mL，p？= 0.0028）。示波器测量显示BDP / F / g对5和20·Hz（R5-R20）AUC 0-12的电阻之间的差异较大，测量小气道阻力（平均差异为0.045？KPA / L / S ，p？=？0.0002）。 BDP / F与基线测量的比较（单独的BDP）显示F增加FEV 1 AUC 0-12（平均差227mL）和改进的RV AUC 0-12（平均差异为558mL）和R5-R20 AUC 0 -12（平均差异为0.117？KPA / L / s），所有p？<？0.0001。结论在COPD患者中的过度下，Extafine BDP / F / G的G和F组分改进了FEV 1，RV和小型气道功能。这些长的支气管扩张剂瞄准小型气道功能，从而改善气体捕获和气流。试用登记该研究在2019年2月15日在Clinicaltrials.gov上回顾性地注册（否。：nct03842904，https://clinicaltrials.gov/ct2/show/nct03842904）。
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