25 September 2017

AstraZeneca today announced positive top-line results of the Phase III, PINNACLE 4 trial in which Bevespi Aerosphere (glycopyrronium and formoterol fumarate 14.4/9.6 µg) demonstrated a statistically significant improvement in lung function as measured by trough forced expiratory volume in one second (FEV1), compared to its monotherapy components (glycopyrronium 14.4 µg and formoterol fumarate 9.6 µg) and placebo, all administered twice daily via pressurised metered-dose inhaler (pMDI) to patients with moderate to very severe chronic obstructive pulmonary disease (COPD). AstraZeneca will make regulatory filing applications for Bevespi Aerosphere in Japan and China in 2018, based on data from PINNACLE 4, as well as previously reported trials.

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