A clinical pharmacology study of fixed <i>vs.</i> free combination of inhaled beclometasone dipropionate and formoterol fumarate dry powder inhalers in asthmatic adolescents

Chawes, Bo; Govoni, Mirco; Piccinno, Annalisa; Kreiner‐Møller, Eskil; Vissing, Nadja Hawwa; Mortensen, Li Juel; Nilsson, Erik; Bisgaard, Amalie; Deleuran, Maja; Skytt, Nanna L.; Samandari, Nasim; Acerbi, Daniela; Bisgaard, Hans

doi:10.1111/bcp.12424

Cited by 3 publications

(4 citation statements)

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“… *One patient was excluded from the PK analysis due to quantifiable concentrations of B17MP at pre‐dose > 5% C max …”

Section: Resultsmentioning

confidence: 99%

“…The systemic exposures at early time points assessed as index of pulmonary absorption (AUC(0,0.5 h)) [18] for the fixed combination was 18% (90% CI 0.64, 1.05) and 3% (90% CI 0.74, 1.20) Values are arithmetic mean (SD), except median (range) for t max . *One patient was excluded from the PK analysis due to quantifiable concentrations of B17MP at pre-dose > 5% C max [11] (Tables 3 and 5). All the pharmacodynamic parameters were equivalent after treatment with the fixed and the free combination.…”

Section: Pharmacokinetics and Pharmacodynamicsmentioning

confidence: 99%

“…The 95% CIs of the geometric mean ratios for potassium C min and AUC(0,t) and for glucose C max , AUC(0,t) and AUC(0,2 h) Values are arithmetic mean (SD), except median (range) for t max . *One patient was excluded from the PK analysis due to quantifiable concentrations of FF at pre-dose > 5% C max [11] were all within the range 0.95, 1.09 (Table 6). Statistical equivalence was observed in mean pulse rate over time (AUC(0,t)/8h) and time-averaged FEV 1 (AUC(0,t)/8h) or peak FEV 1 between the two treatments, 95% CI within the range 0.96, 1.05 (Table 6).…”

Section: Pharmacokinetics and Pharmacodynamicsmentioning

confidence: 99%

“…Thus, assuming a comparable elimination of the drug from the body, the same nominal dose could potentially lead to higher plasma concentrations in adolescents with a consequent increased risk of systemic side effects. Therefore, the optimal dosage for adolescents may be difficult to assess and a careful monitoring of the systemic exposure is critical to assure an appropriate safety profile .…”

Section: Introductionmentioning

confidence: 99%

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Pharmacokinetics and pharmacodynamics of an extrafine fixed pMDI combination of beclometasone dipropionate/formoterol fumarate in adolescent asthma

Kuna

Govoni

Lucci

et al. 2015

Brit J Clinical Pharma

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AIMThe aim was to investigate the pharmacokinetics and pharmacodynamics of an extrafine pressurized metered-dose inhaler (pMDI) fixed combination of beclometasone dipropionate (BDP)/formoterol fumarate (FF) in adolescent and adult asthma. METHODSThis was a three-way crossover study, on 30 asthmatic adolescents receiving BDP/FF pMDI with or without a valved holding chamber (VHC) or a free licenced combination of BDP pMDI and FF pMDI plus a parallel arm of 30 asthmatic adults receiving BDP/FF pMDI. All patients received a single dose of BDP and FF of 400 μg and 24 μg, for each treatment, respectively. Assessments were performed over 8 hours. RESULTSIn adolescents, the 90% confidence intervals (CIs) for the systemic exposure (AUC(0,t)) geometric mean ratio of the fixed combination with or without VHC vs. the free combination were within the bioequivalence range 0.80-1.25, both for beclometasone-17-monopropionate (B17MP, the active metabolite of BDP) and formoterol. Pharmacodynamic variables for plasma potassium and glucose, pulse rate and pulmonary function in adolescents were equivalent between treatments, 95% CI within 0.9, 1.09. The upper level of 90% CIs for AUC(0,t) geometric mean ratio adolescents : adults of B17MP and formoterol after treatment with BDP/FF pMDI was lower than 1.25, 90% CI 0.78, 1.04 and 0.86, 1.17, respectively.

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“… *One patient was excluded from the PK analysis due to quantifiable concentrations of B17MP at pre‐dose > 5% C max …”

Section: Resultsmentioning

confidence: 99%

Section: Pharmacokinetics and Pharmacodynamicsmentioning

confidence: 99%

Section: Pharmacokinetics and Pharmacodynamicsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Pharmacokinetics and pharmacodynamics of an extrafine fixed pMDI combination of beclometasone dipropionate/formoterol fumarate in adolescent asthma

Kuna

Govoni

Lucci

et al. 2015

Brit J Clinical Pharma

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Inhaled steroids with and without regular formoterol for asthma: serious adverse events

Janjua

Schmidt

Ferrer

et al. 2019

Cochrane Database of Systematic Reviews

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Assessing the viability of long-acting β₂-agonists in paediatric asthma patients: a pharmacokinetic/pharmacodynamic perspective

Matera

Rinaldi

Calzetta

et al. 2016

Expert Opinion on Drug Metabolism & Toxicology

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Long-acting β-agonists (LABAs) combined with inhaled corticosteroids (ICSs) are still commonly prescribed to asthmatic children. Unfortunately, pediatric LABA use is based primarily on data from adults, despite the fact that children are not simply small adults and the magnitude of changes in dose exposure and/or exposure response may not be solely reflected by differences in body weight. Areas covered: The differences in pharmacokinetics (PK) and pharmacodynamics (PD) of LABAs are described and discussed with reference children and adults. Expert opinion: Data on the PK behavior of LABAs is very limited and there is almost no data on once-daily LABAs available in the pediatric population. We do not believe that this is due to a fundamental lack of information because therapeutic response and adverse effects are more useful for the optimization of β-agonist treatment than measurement of plasma drug concentrations per se. Nevertheless, population PK-PD studies in children are needed according to the European rules in order to define rational, patient-tailored dosing schemes. Population PK-PD modeling and simulation using non-linear mixed effect modeling should be considered as the preferred tool to develop effective and safe dosing regimens for children because they present an opportunity to analyze sparse and unbalanced datasets, thereby minimizing the burden for each child.

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A clinical pharmacology study of fixed vs. free combination of inhaled beclometasone dipropionate and formoterol fumarate dry powder inhalers in asthmatic adolescents

Cited by 3 publications

References 3 publications

Pharmacokinetics and pharmacodynamics of an extrafine fixed pMDI combination of beclometasone dipropionate/formoterol fumarate in adolescent asthma

Pharmacokinetics and pharmacodynamics of an extrafine fixed pMDI combination of beclometasone dipropionate/formoterol fumarate in adolescent asthma

Inhaled steroids with and without regular formoterol for asthma: serious adverse events

Assessing the viability of long-acting β₂-agonists in paediatric asthma patients: a pharmacokinetic/pharmacodynamic perspective

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A clinical pharmacology study of fixed vs. free combination of inhaled beclometasone dipropionate and formoterol fumarate dry powder inhalers in asthmatic adolescents

Cited by 3 publications

References 3 publications

Pharmacokinetics and pharmacodynamics of an extrafine fixed pMDI combination of beclometasone dipropionate/formoterol fumarate in adolescent asthma

Pharmacokinetics and pharmacodynamics of an extrafine fixed pMDI combination of beclometasone dipropionate/formoterol fumarate in adolescent asthma

Inhaled steroids with and without regular formoterol for asthma: serious adverse events

Assessing the viability of long-acting β2-agonists in paediatric asthma patients: a pharmacokinetic/pharmacodynamic perspective

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Assessing the viability of long-acting β₂-agonists in paediatric asthma patients: a pharmacokinetic/pharmacodynamic perspective