Pulmonary deposition of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler formulated using co-suspension delivery technology in healthy male subjects

This Phase I, randomized, single-dose, two-period crossover study examined the pulmonary deposition of radiolabeled budesonide/glycopyrronium/formoterol fumarate dihydrate delivered via pMDI following a 3- or 10-second breath-hold in healthy male adults. Study participants underwent training in the use of a propellant-only pMDI using the Vitalograph AIM device, which, per the authors, "uses a red/green traffic light system to indicate the correct co-ordination of actuation and inhalation, breath-hold and flow rate".