New three-in-one inhaler delivers improved lung function in patients with moderate to very severe chronic obstructive pulmonary disease.
AztraZeneca reported that a late-stage clinical trial investigating the efficacy of the inhaler PT010, which contains a fixed-dose triple combination therapy for the treatment of patients with moderate to very severe COPD (chronic obstructive pulmonary disease), gave promising results.
COPD is a progressive disease that causes obstruction of airflow in the lungs and affects approximately 329 million people worldwide. By 2020, it is predicted to be the third-leading cause of death. Management of COPD requires control of the daily symptoms – mainly severe breathlessness. Triple combination therapies consisting of an inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA) and long-acting beta2-agonist (LABA) delivered in separate devices are widely prescribed, but most patients must take each medicine using different devices.
According to AstraZeneca, the new PT010 inhaler (budesonide / glycopyrronium / formoterol fumarate 320/14.4/9.6µg using Aerosphere Delivery Technology, in a pressurized metered-dose inhaler or pMDI) showed "statistically significant" improvement compared with dual combination therapies in six out of seven lung function primary endpoints for patients given two inhalations twice per day, in the Phase III KRONOS trial. Overall, eight of the nine primary endpoints were met, and no unexpected safety concerns were identified during KRONOS, which lasted for 24 weeks.
Klaus Rabe, Professor of Pulmonary Medicine at the University of Kiel, Director of the Department of Pneumology at Clinic Grosshansdorf, Germany, and National Co-ordinating Investigator of the KRONOS trial, said: “With the KRONOS trial, we are seeing the potential of PT010 as a triple combination therapy for COPD. I expect the triple class of medicines to play an increasingly important role in addressing the needs of the many COPD patients who are currently undertreated or are receiving triple combination therapy as separate medicines in multiple devices.”
AstraZeneca will submit regulatory applications in Japan and China in the second half of 2018 and are considering filing drug applications in the US and Europe in 2019.