PURPOSE:The pulmonary deposition of an inhaled drug should correlate with its clinical effectiveness. Aclidinium bromide is a novel, long-acting inhaled anticholinergic agent currently in Phase III development for the treatment of chronic obstructive pulmonary disease (COPD). The aim of this study was to assess the lung deposition of aclidinium after inhalation by the Almirall inhaler, a new multidose dry powder inhaler (DPI).
METHODS:In this open-label, Phase I study, a single-dose (200 μg) of radiolabelled (99mTc) aclidinium was administered from the Almirall inhaler at a targeted peak inspiratory flow rate (PIFR) of 90 L/min in 12 healthy male subjects (18–65 years). Scintigraphic images of the thorax, head and inhaler device were obtained immediately after administration. Data were analyzed to quantify the percentage of metered dose deposited in the whole lung (including six regions within the lungs).
RESULTS:The PIFR (mean ± SD) reached by the subjects was 79 ± 9 L/min. The mean ± SD percentage of the aclidinium metered dose deposited in the whole lung was 30.1 ± 7.3%. Within the lungs, deposition in the most central region was 9.9 ± 3.3% and 2.6 ± 1.0% in the most peripheral region.
CONCLUSION:After inhalation of aclidinium through the Almirall inhaler, approximately 30% of the metered dose is deposited in the lungs. This suggests that the new Almirall inhaler is an efficient DPI that can be used to deliver inhaled drugs.
CLINICAL IMPLICATIONS:In another study, COPD patients using the Almirall inhaler generated a peak inspiratory flow that was greater than that seen in the healthy subjects in this study. Given these results, a similar whole lung deposition is expected in COPD patients as in healthy subjects.
DISCLOSURE:Roland Greguletz, Employee The presenter is currently employed at Almirall Sofotec GmbH. Almirall SA is a pharmaceutical company that intends to register and commercialize Aclidinium bromide. Product/procedure/technique that is considered research and is NOT yet approved for any purpose. Aclidinium bromide is in clinical development and has not yet been approved for its commercial use for the treatment of COPD.