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首页> 外文期刊>Pulmonary pharmacology & therapeutics >Tolerability of high cumulative doses of the HFA modulite beclomethasone dipropionate/formoterol combination inhaler in asthmatic patients.
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Tolerability of high cumulative doses of the HFA modulite beclomethasone dipropionate/formoterol combination inhaler in asthmatic patients.

机译：哮喘患者中高累积剂量的HFA模块化双氯米松双丙酸酯/福莫特罗联合吸入剂的耐受性。

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The corticosteroid beclomethasone dipropionate (BDP) has been formulated with the long acting beta agonist formoterol (BDP/formoterol 100mug/6mug, Fostertrade mark) in a single inhaler using Modulite((R)) technology. We have investigated the acute tolerability of high, cumulative doses of BDP/formoterol compared to formoterol alone and placebo. This was a double blind, 3-way cross-over comparison of 10 puffs of BDP/formoterol 100mug/6mug or formoterol 6mug or placebo during maintenance treatment with BDP/formoterol two puffs per day. Pharmacokinetics over 12h during maintenance treatment was measured on day 7. High cumulative doses were then administered on three separated days. Eighteen patients with asthma were recruited (mean FEV(1) 65% predicted). The primary endpoint was serum potassium over the 12h period after high doses. QTc, blood pressure and heart rate over 12h, and plasma lactate and glucose over 3h following dosing were assessed. Formoterol caused a significantly greater decrease in serum potassium than BDP/formoterol or placebo (difference in mean minimum concentrations; 0.11 and -0.15mmol/l, respectively, p<0.05 for both comparisons). No significant differences in serum potassium parameters were found between BDP/formoterol and placebo. QTc, plasma lactate and vital signs values observed with the combination were not statistically different from those with formoterol alone. For glucose, the mean maximum increase after formoterol treatment was 0.4mmol/l (p<0.01 compared to placebo), while BDP/formoterol treatment caused a maximum increase of 0.7mmol/l (p<0.01 compared to formoterol and placebo). The active metabolite of BDP is beclomethasone-17-monopropriate (B17MP), which reached C(max) at 0.25h, with an elimination half-life of 3.7h. Formoterol also reached C(max) at 0.25h, and concentrations were measurable up to 12h. High doses of BDP/formoterol did not significantly reduce serum potassium, while formoterol alone did to a greater extent. The BDP/formoterol combination was well tolerated, and exhibited a safety profile generally similar to formoterol alone when administered in high doses to stable asthmatic patients.
机译：皮质类固醇倍氯米松二丙酸酯（BDP）已与长效β激动剂福莫特罗（BDP /福莫特罗100杯/ 6杯，Fostertrade商标）一起通过Modulite®技术配制在一个吸入器中。与单独使用福莫特罗和安慰剂相比，我们已经研究了高累积剂量的BDP /福莫特罗的急性耐受性。这是每天两次用BDP /福莫特罗进行维持治疗期间，对10克BDP /福莫特罗100杯/ 6 ug或福莫特罗6杯或安慰剂进行的双盲，3次交叉比较。在第7天对维持治疗期间12h内的药代动力学进行了测量。然后在3天中分别给予高累积剂量。招募了18名哮喘患者（预测的FEV（1）平均为65％）。主要终点是高剂量后12小时内的血清钾。给药后评估QTc，超过12小时的血压和心率，以及超过3小时的血浆乳酸和葡萄糖。与BDP /福莫特罗或安慰剂相比，福莫特罗引起的血清钾下降显着更大（平均最低浓度差异;分别为0.11和-0.15mmol / l，两个比较均p <0.05）。 BDP /福莫特罗和安慰剂之间的血清钾参数无显着差异。联合使用时观察到的QTc，血浆乳酸和生命体征值与单独使用福莫特罗的情况无统计学差异。对于葡萄糖，福莫特罗治疗后的平均最大增幅为0.4mmol / l（与安慰剂相比，p <0.01），而BDP /福莫特罗治疗引起的最大增幅为0.7mmol / l（与福莫特罗和安慰剂相比，p <0.01）。 BDP的活性代谢物是倍氯米松17一丙酸酯（B17MP），在0.25h达到C（max），消除半衰期为3.7h。福莫特罗在0.25h时也达到C（max），浓度可测量到12h。高剂量的BDP /福莫特罗并未显着降低血清钾，而单独的福莫特罗则在更大程度上降低了血钾。 BDP /福莫特罗组合具有良好的耐受性，当向稳定的哮喘患者高剂量给药时，其安全性通常与单独使用福莫特罗相似。

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