Successful Phase III KRONOS trial for PT 010 for treatment of COPD.- AstraZeneca

AstraZeneca has announced top-line results from the Phase III KRONOS trial that showed PT 010 (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6�g, using Aerosphere Delivery Technology, in a pressurised metered-dose inhaler or pMDI) demonstrated a statistically significant improvement in eight out of nine lung function primary endpoints based on forced expiratory volume in one second (FEV1) assessments in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

KRONOS is a randomised, double-blind, parallel-group, 24-week, chronic-dosing, multi-centre trial to assess the efficacy and safety of PT 010. The trial compared PT 010 to Bevespi Aerosphere (glycopyrronium/formoterol fumarate 14.4/9.6�g pMDI), Symbicort Turbuhaler (budesonide/formoterol fumarate 400/12�g) and PT009 (budesonide/formoterol fumarate 320/9.6�g using Aerosphere Delivery Technology in a pMDI, being characterised to qualify as a relevant comparator in clinical trials for PT 010). Patients were given two inhalations twice a day of PT 010, PT 009, Bevespi Aerosphere or Symbicort Turbuhaler. There were no unexpected safety or tolerability signals for PT 010 identified in the trial.

Comment: The ETHOS exacerbation trial will report in 2019.