# AstraZeneca provides update on AERISTO Phase IIIb trial

- Link: https://www.directorstalkinterviews.com/astrazeneca-provides-update-aeristo-phase-iiib-trial/412757107
- Published: 2018-08-23T07:13:18+01:00
- Author: Giles Arbor

**[AstraZeneca Plc](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON:AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l))
today announced top-line results from the AERISTO Phase IIIb trial for Bevespi Aerosphere(
glycopyrronium/formoterol fumarate) in patients with moderate to very severe chronic
obstructive pulmonary disease (COPD). In the trial, Bevespi Aerosphere demonstrated
non-inferiority to umeclidinium/vilanterol on peak forced expiratory volume in one
second (FEV1) but did not demonstrate superiority on peak FEV1 or non-inferiority
on trough FEV1.

Dr Colin Reisner, Head of Respiratory, Global Medicines Development, 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 24-week AERISTO Phase IIIb trial was a randomised, double-blinded, double-dummy,
multicentre, parallel-group trial designed to assess the efficacy and safety of 
Bevespi Aerosphere compared with umeclidinium/vilanterol. The 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.
In the trial, 1,119 patients were randomised to receive either two inhalations twice
a day of Bevespi Aerosphere (glycopyrronium/formoterol fumarate 7.2/4.8µg) via pressurised
metered-dose inhaler or one inhalation once a day of umeclidinium/vilanterol 62.5/
25µg via dry powder inhaler. Safety and tolerability data for Bevespi Aerosphere
were consistent with the known profile of the medicine.

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 plc is a global, science-led biopharmaceutical company that focuses 
on the discovery, development and commercialisation of prescription medicines, primarily
for the treatment of diseases in three therapy areas – Oncology, Cardiovascular,
Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and
its innovative medicines are used by millions of patients worldwide.

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