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Extrafine Beclometasone Dipropionate and Formoterol in Single and Separate Inhalers
Piccinno A, Poli G, Monno R, Goethals F, Nollevaux F and Acerbi D
The aim of this study was to evaluate the pharmacokinetics and pharmacodynamics of single administration of extrafine beclometasone (BDP)/formoterol hydrofluoroalkane (HFA) (Foster®, Chiesi Farmaceutici S.p.A., Italy) by pressurized metered dose inhaler (pMDI) in healthy volunteers, compared to the free combination of extrafine BDP pMDI (QVAR®, 3 M) and extrafine formoterol pMDI (Atimos®, Chiesi Farmaceutici S.p.A.) delivered via separate inhalers.
Twelve healthy male volunteers completed this open label, randomized, single-dose, placebo-controlled, threeway cross-over study. Volunteers received (i) 4 inhalations of the fixed-combination of BDP/formoterol HFA (100/6 μg), (ii) 4 inhalations of BDP HFA (100 μg) and 2 inhalations of formoterol HFA (12 μg) administered separately or (iii) 4 inhalations of placebo HFA. There was a 7-day washout between treatment periods.
PK parameters of BDP, FF, and of the main BDP metabolite (B17MP) were calculated.
The systemic exposure to B17MP and formoterol after administration as a fixed combination or via separate inhalers was comparable. For B17MP, Cmax (794 ± 316 vs 663 ± 329 pg/mL), AUC0-t (3076 ± 1102 vs 2773 ± 833 pg.h/mL) and AUC0-30min (296 ± 11.7 vs 230 ± 13.3 pg.h/mL) were slightly higher, but not statistically significant, with the fixed than with the free combination.
For formoterol, neither Cmax (27.6 ± 12.2 vs 28.7 ± 16.3 pg/mL) nor AUC0-t (69.3 ± 28.5 vs 67.4 ± 28.7 pg.h/mL) were significantly different between fixed and free combination. There was also no significant difference between the two combinations in serum cortisol levels, or cortisol urinary excretion adjusted for creatinine.
Use of a single inhaler rather than separate inhalers to deliver extrafine drug particles of both BDP and formoterol to the lung does not modify relevant pharmacokinetics and pharmacodynamic parameters in healthy volunteers, therefore it may be considered as a therapeutic option to improve compliance in asthma patients who need chronic treatment.