Lung deposition and distribution of inhaled extra fine beclomethasone dipropionate / formoterol fumarate /glycopyrronium bromide (BDP/FF/GB) in subjects with and without airflow obstruction

Aims and Objectives: Delivery of therapeutic aerosols to peripheral airways is key in the treatment of asthma. We investigated the lung deposition and distribution of extra fine BDP/FF/GB inhalation solution delivered via a pressurised metered-dose inhaler (pMDI) in subjects with asthma and healthy volunteers. Methods: Subjects underwent gamma scintigraphy after 4 inhalations of technetium (99mTc) radiolabelled BDP/FF/GB, 100/6/12.5 mcg. After correcting for 99mTc decay, tissue attenuation and background radioactivity, total lung deposition was expressed as percent of nominal dose (DL%ND), and intra-pulmonary drug distribution (right lung only) as the fraction of 99mTc labelled aerosol and krypton (81mKr) gas in the central (C) and peripheral (P) regions of interest. The C/P ratio was calculated for the 99mTc aerosol and 81mKr gas and their ratio is referred to as standardised C/P (sC/P). Results: Nine asthmatics (6 males, FEV1 61 – 76 % predicted, 32-48 years) and 10 healthy subjects (6 males, FEV1 89 - 120 % predicted, 28-49 years) completed the study. No differences were observed in lung deposition and distribution parameters (Table): Conclusions: Lung deposition of extra fine BDP/FF/GB pMDI is comparable between healthy subjects and patients with mild-moderate asthma and is well dispersed across the central and peripheral lung regions.