AstraZeneca has reported negative top-line results from the AERISTO trial, a Phase IIIb study of Bevespi Aerosphere (glycopyrronium/formoterol fumarate) against umeclidinium/vilanterol for the treatment of patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
The results have revealed that Bevespi Aerosphere showed non-inferiority to umeclidinium/vilanterol on peak forced expiratory volume in one second (FEV1), but did not show improvement on peak FEV1 or non-inferiority on trough FEV1.
The trial, however, showed that the safety and tolerability data of Bevespi Aerosphere were consistent with the known profile of the medicine.
Bevespi Aerosphere is a fixed-dose combination of dual bronchodilator combining glycopyrronium, a long-acting muscarinic agonist (LAMA), and a long-acting beta2-agonist (LABA) formoterol fumarate.
AstraZeneca Respiratory and Global Medicines Development head Dr Colin Reisner said: “The efficacy and safety of Bevespi Aerosphere has been established by the Phase III PINNACLE trial programme involving more than 5,000 patients.
“The performance of Bevespi Aerosphere in AERISTO is inconsistent with previous data.
“A full analysis is underway to understand and characterise these findings and will be presented at a forthcoming medical meeting.”
The AERISTO included a 24-week, randomised, double-blinded, double-dummy, multicentre, parallel-group trial design.
It evaluated the efficacy and safety of Bevespi Aerosphere in comparison with umeclidinium/vilanterol in 1,119 COPD patients.
During the trial, the patients were randomised to receive either two inhalations twice a day of Bevespi Aerosphere 7.2µg/4.8µg via a pressurised metered-dose inhaler or one inhalation once a day of umeclidinium/vilanterol 62.5µg/25µg via dry powder inhaler.
Primary objectives of the AERISTO were peak change from baseline in FEV1 where non-inferiority and superiority were measured, as well as change from baseline in trough FEV1 where non-inferiority was measured.