Chiesi is developing a portfolio of MDI products containing a new propellant (HFA-152a) with lower global warming potential and comparable pharmacokinetic parameters to currently marketed MDIs containing HFA-134a, with the aim to maintain the range of treatments for asthma and COPD patients, while lowering the environmental impact.

This phase I, single-center, single-dose, randomised, double-blind, 4-way cross-over study in 71 healthy volunteers was conducted to demonstrate bioequivalence between the new formulation (containing HFA-152a) of beclometasone dipropionate (BDP), formoterol fumarate (FF) and glycopyrronium bromide (GB) 200/6/12.5 µg, and the current formulation (containing HFA-134a) indicated for severe asthmatic patients. Treatments were compared both with and without prior administration of activated charcoal to assess lung delivery and total systemic exposure, respectively. Serial blood samples were collected to assess primary pharmacokinetic endpoints: the maximum concentration and area under the curve for BDP, B17MP, FF and GB.

Bioequivalence was fully demonstrated for BDP/B17MP and FF. For GB, 90% CIs were marginally above the bioequivalence upper limit. These minor mismatches were considered not clinically relevant. This study supports bioequivalence between the two formulations and the timely introduction of treatment options enabling seamless transition for patients, while minimizing environmental impact.

Similar positive results have been obtained with the medium dose formulation of the same product.