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P6 Relative lung availability and total systemic exposure after inhalation of medium or high strength doses of beclometasone dipropionate/formoterol fumarate, formulated as pMDI with a next generation propellant
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P6 Relative lung availability and total systemic exposure after inhalation of medium or high strength doses of beclometasone dipropionate/formoterol fumarate, formulated as pMDI with a next generation propellant
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P6 Relative lung availability and total systemic exposure after inhalation of medium or high strength doses of beclometasone dipropionate/formoterol fumarate, formulated as pMDI with a next generation propellant
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Journal Article
P6 Relative lung availability and total systemic exposure after inhalation of medium or high strength doses of beclometasone dipropionate/formoterol fumarate, formulated as pMDI with a next generation propellant
2025
Overview
BackgroundGrowing concern around the global warming potential (GWP) of hydrofluoroalkane 134a (HFA-134a) propellant used in pressurized metered dose inhaler (pMDI) for asthma and COPD has prompted research into alternatives like HFA-152a, with a significantly lower GWP.A new formulation of CHF1535 [beclometasone dipropionate (BDP)/formoterol fumarate (FF)] 100/6 µg medium strength (MS) and 200/6 µg high strength (HS) has been developed with HFA-152a. Bioequivalence with CHF1535 HFA-134a marketed formulation should be demonstrated for BDP, B17MP (active metabolite of BDP) and Formoterol.MethodsTwo single-dose, double-blind, randomized, 4-way crossover studies with CHF1535 MS or HS were conducted in healthy volunteers, administered with a single dose of 4 inhalations of each formulation with HFA-152a or HFA-134a, with and without the use of the AeroChamber Plus® spacer. Primary PK endpoints were Cmax, AUC0-t and tmax for all analytes and AUC0–30 min for Formoterol only, to assess lung availability and systemic effect. Safety was monitored.ResultsThe 90% confidence intervals of all PK parameter ratios between HFA-152a and HFA-134a for lung availability and total systemic exposure were within the bioequivalence acceptance interval (80.00–125.00%) for both strengths, with and without the spacer. There was no shift in median tmax. No safety signals were observed.ConclusionsTherapeutic equivalence between the two formulations was demonstrated, supporting the timely introduction of therapeutic options enabling a seamless transition for patients, while minimizing climate impact.
Publisher
BMJ Publishing Group LTD
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