Phase III trial results of PT010 combination therapy in COPD

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AstraZeneca has announced publication of results from the KRONOS Phase III trial which evaluated the efficacy and safety of triple combination therapy PT010 (budesonide/ glycopyrronium/formoterol fumarate) versus dual combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate), Symbicort Turbuhaler (budesonide/formoterol fumarate) and PT009 (budesonide/formoterol fumarate) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) regardless of whether or not they had an exacerbation in the prior year.

The KRONOS trial met eight of the nine primary lung function endpoints and, in a key secondary endpoint, PT010 showed a statistically significant 52% reduction in the rate of moderate or severe COPD exacerbations compared with Bevespi Aerosphere in a patient population that was not required to have had an exacerbation in the previous 12 months. PT010 also demonstrated reductions in the rate of moderate or severe COPD exacerbations versus PT009 and Symbicort (18% and 17% respectively), which were numerically but not statistically significant improvements. The incidence of adjudicated pneumonia was low and comparable in all treatment arms.

There were no new or unexpected safety or tolerability signals for PT010 in the KRONOS trial, and the adverse events profile was consistent with that observed in previous trials.

Dr Colin Reisner, Head of Respiratory, Global Medicines, said: “We are encouraged by the results of the KRONOS trial which demonstrate PT010’s efficacy in improving lung function and its potential value as a triple combination therapy for patients with COPD. Importantly, PT010 also halved the rate of moderate or severe exacerbations compared to glycopyrronium/formoterol fumarate and we look forward to the ETHOS exacerbation trial results in 2019 to further characterise PT010.”

Gary Ferguson, Professor of the Pulmonary Research Institute of Southeast Michigan, Livonia, Michigan and lead author of the KRONOS trial publication, said: “Preventing exacerbations is a priority in the management of COPD because they are known to have an impact on lung function and mortality, and patients are at risk even if they haven’t had an exacerbation in the previous 12 months. The KRONOS trial demonstrated that PT010 reduces the risk of an exacerbation versus LAMA/LABA combination therapy in symptomatic COPD patients regardless of whether or not they’ve had an exacerbation in the previous year.”