Pharmacokinetics, pharmacodynamics and safety of a novel extrafine BDP/FF/GB combination delivered via metered-dose inhaler in healthy Chinese subjects

Hu, Chao; Miao, Jia; Shu, Shiqing; Wang, Ying; Zhu, Xiaoyan; Luo, Zhu

doi:10.1016/j.ejps.2019.105198

Cited by 4 publications

(3 citation statements)

References 34 publications

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“… 2 In addition, the pharmacokinetic (PK) profile of BDP/FF/GB has previously been investigated in adult healthy volunteers, with the dose‐adjusted PK profile similar for therapeutic and supra‐therapeutic doses, and no evidence of any impact of ethnicity on PK or safety parameters. 3 , 4 …”

Section: Introductionmentioning

confidence: 99%

“…2 In addition, the pharmacokinetic (PK) profile of BDP/FF/GB has previously been investigated in adult healthy volunteers, with the dose-adjusted PK profile similar for therapeutic and supra-therapeutic doses, and no evidence of any impact of ethnicity on PK or safety parameters. 3,4 The efficacy and safety of BDP/FF/GB in adolescents (i.e., aged 12-17 years ) have not yet been investigated, and use in this age group is not currently licensed. However, given treatment guidelines do not make a distinction between adults and adolescents in terms of maintenance therapy options, 1 and no single-inhaler triple therapy is currently approved for asthma in this age group, the development of BDP/FF/GB for adolescents can help fulfill an unmet need.…”

Section: Introductionmentioning

confidence: 99%

“…In two 52‐week randomized clinical trials in adults with asthma that was uncontrolled by medium‐ or high‐dose ICS plus LABA, extrafine BDP/FF/GB improved lung function and reduced the rate of moderate‐and‐severe asthma exacerbations compared with extrafine BDP/FF 2 . In addition, the pharmacokinetic (PK) profile of BDP/FF/GB has previously been investigated in adult healthy volunteers, with the dose‐adjusted PK profile similar for therapeutic and supra‐therapeutic doses, and no evidence of any impact of ethnicity on PK or safety parameters 3,4 …”

Section: Introductionmentioning

confidence: 99%

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Pharmacokinetics of extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide in adolescent and adult patients with asthma

Kuna

Jerzyńska

Martini

et al. 2022

Pharmacology Res & Perspec

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The single‐inhaler extrafine formulation triple combination beclometasone dipropionate (BDP), formoterol fumarate (FF) plus glycopyrronium bromide (GB) is available for asthma management in adults. Its use in adolescents has not yet been evaluated. This study investigated the pharmacokinetic profile of BDP/FF/GB in adults and adolescents, with the aim of ruling out higher plasma exposure in adolescents compared to adults. In this open‐label, non‐randomized study, patients with asthma aged 12–17 (adolescents) and 18–64 years (adults) self‐administered a single dose of BDP/FF/GB 400/24/50 μg via pressurized metered‐dose inhaler (pMDI). The primary objective was to rule out higher systemic exposure to beclometasone 17‐monopropionate (B17MP; active metabolite of BDP), formoterol, and GB in terms of the area under the plasma concentration‐time curve from 0 to the last quantifiable concentration (AUC 0– t ) in adolescents versus adults. A total of 40 adolescents and 40 adults entered the study (mean age of 14.8 and 43.6 years, respectively). The primary objective (AUC 0– t ) was met, with the upper 90% confidence interval of the geometric mean ratio between adolescents and adults <125% for B17MP (point estimate 79.28 [90% CI 71.19; 88.29]), formoterol (88.68 [77.71; 101.20]) and GB (85.49 [72.96; 100.16]). All secondary pharmacokinetic endpoints supported the primary, with pharmacodynamic (safety) and tolerability results similar in the two populations. In conclusion, systemic exposure to extrafine BDP/FF/GB pMDI in adolescents was not higher than that in adults. Furthermore, there were no safety or tolerability signals to warrant a reduction in the dose of BDP/FF/GB for adolescents with asthma.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%