AstraZeneca has reported positive top-line results from the Phase III PINNACLE 4 clinical trial of Bevespi Aerosphere to treat moderate to very severe chronic obstructive pulmonary disease (COPD).

The results showed statistically significant improvement in lung function compared with twice-daily placebo and monotherapy components, 14.4µg of glycopyrronium and 9.6µg of formoterol fumarate.

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Bevespi Aerosphere is a fixed-dose dual bronchodilator comprising a combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA), and long-acting beta-2 adrenergic agonist (LABA) formoterol fumarate.

The PINNACLE 4 trial evaluated the safety and efficacy of twice-daily Bevespi Aerosphere administered through pressurised metered-dose inhaler (pMDI) in 1,756 subjects over 24 weeks in Asia, Europe and the US.

AstraZeneca Global Medicines Development Respiratory head Dr Colin Reisner said: “These positive results add to the strong established efficacy and safety profile of Bevespi Aerosphere in the treatment of patients with COPD.

“These positive results add to the strong established efficacy and safety profile of Bevespi Aerosphere in the treatment of patients with COPD.”

“PINNACLE 4 will support our regulatory filings in Japan and China where respiratory diseases such as COPD remain a significant and growing public health burden with unmet treatment needs.”

The primary outcome of the Phase III trial was the change in morning pre-dose from baseline, while secondary outcomes were dyspnoea, health-related quality of life, time to onset and use of rescue medication.

It was observed that the safety and tolerability data for Bevespi Aerosphere in the PINNACLE 4 trial was consistent with the findings from previous trials.

The firm intends to carry out the regulatory filings for the drug in Japan and China next year.