23rd Aug 2018 08:03
LONDON (Alliance News) - AstraZeneca PLC on Thursday said the 24-week Aeristo Phase IIIb trial for a fixed-dose dual bronchodilator Bevespi Aerosphere was inconsistent with previous data.
The trial aimed to assess the efficacy and safety of Bevespi Aerosphere compared with umeclidinium/vilanterol.
In the research, 1,119 patients with moderate to very severe chronic obstructive pulmonary disease were randomised to receive either two inhalations twice a day of Bevespi Aerosphere or one inhalation once a day of umeclidinium/vilanterol.
The FTSE 100-listed pharmaceutical company said Bevespi Aerosphere showed non-inferiority to umeclidinium/vilanterol on peak forced expiratory volume in one second in the trial, but did not demonstrate superiority on peak forced expiratory volume in one second or non-inferiority on trough forced expiratory volume in one second.
Bevespi Aerosphere is currently approved in the US and Canada for the long-term maintenance treatment of airflow obstruction. The treatment is currently under review by the European Medicines Agency with a regulatory decision anticipated in the second half of 2018.
"The efficacy and safety of Bevespi Aerosphere has been established by the Phase III Pinnacle trial programme involving more than 5,000 patients," said Colin Reisner, head of respiratory at Global Medicines Development.
"The performance of Bevespi Aerosphere in Aeristo is inconsistent with previous data," Reisner continued. "A full analysis is underway to understand and characterise these findings and will be presented at a forthcoming medical meeting."
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