In the trial, Bevespi Aerosphere, a rival COPD treatment to GSK’s product, showed non-inferiority to umeclidinium/vilanterol on peak forced expiratory volume in one second (FEV1) but and failed to demonstrate superiority on peak FEV1 or non-inferiority on trough FEV1.
Bevespi Aerosphere is a fixed-dose dual bronchodilator that combines glycopyrronium and formoterol fumarate.
Glycopyrronium is a long-acting muscarinic agonist (LAMA), while formoterol fumarate is a long-acting beta2-agonist (LABA). ). Bevespi Aerosphere is claimed to be the first and only LAMA/LABA with Aerosphere delivery technology.
The 24-week Aeristo phase IIIb study was a randomised, double-blinded, double-dummy, multicentre and parallel-group trial designed to evaluate the efficacy and safety of Bevespi Aerosphere against umeclidinium/vilanterol.
According to the company, the trial’s primary endpoints were peak change from baseline in FEV1 where non-inferiority and superiority were measured and change from baseline in trough FEV1 where non-inferiority was measured.
The company randomized 1,119 patients in the study to receive either two inhalations twice a day of Bevespi Aerosphere (glycopyrronium/formoterol fumarate 7.2/4.8µg) through pressurised metered-dose inhaler or one inhalation once a day of umeclidinium/vilanterol 62.5/25µg via dry powder inhaler.
Bevespi Aerosphere already approved in the US and Canada for the long-term maintenance treatment of airflow obstruction in COPD.
At present, it is being reviewed by the European Medicines Agency and regulatory decision is expected in the second half of this year.
Bevespi Aerosphere is approved in the US and Canada for the long-term maintenance treatment of airflow obstruction in COPD. Bevespi Aerosphere is currently under review by the European Medicines Agency with a regulatory decision anticipated in the second half of 2018.
AstraZeneca respiratory 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.”