Clinical Data
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.1 Further details on the primary endpoints are outlined below.


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. The most frequently reported adverse events were nasopharyngitis, upper respiratory tract infection, COPD, bronchitis, muscle spasms, dysphonia, hypertension, dyspnoea, back pain and nausea. The incidence of adjudicated pneumonia was low and comparable among PT010 (1.9%), Bevespi Aerosphere (1.6%), PT009 (1.9%) and Symbicort Turbuhaler (1.3%).