Children's Clinic Randers, Randers, Denmark.
Clin Ther. 2011 Aug;33(8):1069-76. doi: 10.1016/j.clinthera.2011.06.015. Epub 2011 Jul 23.
Beclomethasone dipropionate-hydrofluoroalkane (BDP-HFA) is a non-chlorofluorocarbon (CFC)-propelled metered dose inhaler. Data is needed to support the registration of BDP-HFA in pediatric populations for countries in the European Union.
The aim of the study was to assess short-term lower leg growth in children with asthma during treatment with BDP-HFA 100 μg BID compared with BDP-CFC 200 μg BID.
Children with asthma were included in this open-label, randomized, crossover study with 2-week run-in, active treatment, and washout periods. Lower leg length was measured every second week. As a secondary outcome parameter, 24-hour urine was collected for assessment of free cortisol. Interventions were inhaled BDP-HFA 100 μg BID with AeroChamber Plus spacer and BDP-CFC 200 μg BID with Volumatic spacer.
In 63 patients with asthma aged 5 to 11 years, BDP-HFA 100 μg BID was noninferior to BDP-CFC 200 μg BID, as the lower margin of CI (-0.03 to 0.10 mm/wk) of the estimated difference (0.03 mm/wk) was greater than the prespecified lower limit for noninferiority of -0.12 mm/wk. Mean (SD) lower leg growth rate during run-in, BDP-HFA 100 μg BID, and BDP-CFC 200 μg BID was 0.36 (0.17), 0.27 (0.21), and 0.23 (0.18) mm/wk, respectively (BDP-HFA estimate of difference, -0.09 [95% CI, -0.16 to -0.03 mm/wk; P < 0.01]; BDP-CFC estimate of difference, -0.13 [95% CI, -0.19 to -0.06 mm/wk; P < 0.001]). No statistically significant differences were seen in urinary free cortisol assessments. Eight and 6 mild to moderate adverse events in 10 children were reported during treatment with BDP-HFA and BDP-CFC, respectively. One event in each group was judged to be probably related to the study medication; no others were judged to be related.
No statistically significant differences were found in lower leg growth between BDP-HFA 100 μg BID with AeroChamber Plus spacer and BDP-CFC 200 μg BID with Volumatic spacer during 2-week treatment. Evidence of differences in systemic activity between the treatments was not found. EudraCT registration: 2007-007455-14.
倍氯米松二丙酸盐- 氢氟烷烃（BDP-HFA）是一种非氯氟碳化物（CFC）推进的计量吸入器。需要数据来支持 BDP-HFA 在欧盟国家的儿科人群中的注册。
本研究旨在评估哮喘儿童在接受 BDP-HFA 100μg BID 治疗与 BDP-CFC 200μg BID 治疗期间的小腿短期生长情况。
本开放标签、随机、交叉研究纳入了哮喘儿童，为期 2 周的导入期、活性治疗期和洗脱期。每两周测量一次小腿长度。作为次要结局参数，收集 24 小时尿液以评估游离皮质醇。干预措施为吸入 BDP-HFA 100μg BID 与 AeroChamber Plus 喷雾器和 BDP-CFC 200μg BID 与 Volumatic 喷雾器。
在 63 名年龄在 5 至 11 岁的哮喘患儿中，BDP-HFA 100μg BID 与 BDP-CFC 200μg BID 无差异，因为估计差异的置信区间下限（-0.03 至 0.10mm/wk）（0.03mm/wk）大于预定的非劣效性下限-0.12mm/wk。在导入期、BDP-HFA 100μg BID 和 BDP-CFC 200μg BID 期间，平均（SD）小腿生长速度分别为 0.36（0.17）、0.27（0.21）和 0.23（0.18）mm/wk（BDP-HFA 估计差异，-0.09[95%CI，-0.16 至-0.03mm/wk；P<0.01]；BDP-CFC 估计差异，-0.13[95%CI，-0.19 至-0.06mm/wk；P<0.001]）。尿游离皮质醇评估无统计学显著差异。在接受 BDP-HFA 和 BDP-CFC 治疗的 10 名儿童中，分别有 8 名和 6 名出现 1 至 2 例轻度至中度不良事件。两组各有 1 例事件被判断为可能与研究药物有关；其他事件均未被判断为与研究药物有关。
在为期 2 周的治疗期间，BDP-HFA 100μg BID 联合 AeroChamber Plus 喷雾器与 BDP-CFC 200μg BID 联合 Volumatic 喷雾器治疗在小腿生长方面未发现统计学显著差异。未发现两种治疗方法在全身活性方面的差异。EudraCT 注册号：2007-007455-14。
