Morice Alyn H, McGarvey Lorcan, Pavord Ian D, Higgins Bernard, Chung Kian Fan, Birring Surinder S
Hull York Medical School, Castle Hill Hospital, Hull, UK.
Centre for Experimental Medicine, Queen's University Belfast, Belfast, Northern Ireland.
J Thorac Dis. 2017 Jul;9(7):1864-1872. doi: 10.21037/jtd.2017.06.18.
To investigate the effect of BC1036 on health-related quality of life (QOL) in subjects with persistent cough. The secondary objective was to investigate the effect of BC1036 on subjective cough severity.
This was a randomised, multicentre, double-blind, placebo-controlled, parallel-group study in 289 subjects with persistent cough. Subjects received BC1036 or placebo twice daily for 14 days. The primary endpoint comprised cough-related QOL assessed using the validated Leicester Cough Questionnaire (LCQ) at Day 14. Secondary endpoints comprised the LCQ scores at Day 7 and Day 28, cough severity VAS scores at each visit and pulmonary function tests.
At baseline, mean total LCQ score in the BC1036 group was lower (i.e., worse QOL) than placebo (P<0.001), indicating significant between-group heterogeneity. Mean baseline-adjusted change in LCQ score at Day 14 was greater for BC1036 [mean (SD) 2.4±3.5] compared to placebo [mean (SD) score 2.2±3.0], but did not reach statistical significance (P=0.60). Mean cough severity VAS score decreased to a greater extent in the BC1036 group compared to placebo, but again the results were not statistically significant (-12.2±23.28 in BC1036 group and -11.0±21.34 in placebo group at Day 14, P=0.688). There was no significant change in pulmonary function measurements. The adverse event (AE) profile was similar in both groups.
This study showed that BC1036 was well tolerated and, although the primary endpoint did not achieve statistical significance, the magnitude of improvement was greater with BC1036 compared to placebo with respect to improving QOL and reducing cough severity.
ClinicalTrials.gov: NCT01656668.
研究BC1036对持续性咳嗽患者健康相关生活质量（QOL）的影响。次要目标是研究BC1036对主观咳嗽严重程度的影响。
这是一项针对289名持续性咳嗽患者的随机、多中心、双盲、安慰剂对照、平行组研究。受试者每天服用两次BC1036或安慰剂，持续14天。主要终点是在第14天使用经过验证的莱斯特咳嗽问卷（LCQ）评估的与咳嗽相关的生活质量。次要终点包括第7天和第28天的LCQ评分、每次访视时的咳嗽严重程度视觉模拟评分（VAS）以及肺功能测试。
在基线时，BC1036组的平均总LCQ评分低于安慰剂组（即生活质量更差）（P<0.001），表明组间存在显著异质性。与安慰剂组[平均（标准差）评分2.2±3.0]相比，BC1036组在第14天的平均基线调整后LCQ评分变化更大[平均（标准差）2.4±3.5]，但未达到统计学显著性（P=0.60）。与安慰剂组相比，BC1036组的平均咳嗽严重程度VAS评分下降幅度更大，但结果同样无统计学显著性（第14天，BC1036组为-12.2±23.28，安慰剂组为-11.0±21.34，P=0.688）。肺功能测量无显著变化。两组的不良事件（AE）情况相似。
本研究表明BC1036耐受性良好，尽管主要终点未达到统计学显著性，但在改善生活质量和降低咳嗽严重程度方面，BC1036相对于安慰剂的改善幅度更大。
ClinicalTrials.gov：NCT01656668。
