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AZ Reports Phase III Results for PT010 in COPD
AZ Reports Phase III Results for PT010 in COPD.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 1206D AstraZeneca PLC 26 January 2018 \n\n26 January 2018 18:20 GMT\n \nGENERAL TEXT AMENDMENT\n \nThe following amendments have been made to the 'AZ Reports Phase III Results for PT010 in COPD' announcement released on 26/01/2018 at 07:00 under RNS No 9902C.\n \nThese amendments are to correct text, delineating the PT010 superiority primary endpoints from the comparator PT009 non-inferiority primary endpoints:\n \n· Subhead amended from \"eight out of nine\" to \"six out of seven.\"\n \n· First sentence amended from \"in eight out of nine\" to \"compared with dual combination therapies in six out of seven.\"\n \n· Body copy amended to include: \"In total, eight of the nine primary endpoints in the KRONOS trial were met, including two non-inferiority endpoints to qualify PT009, one of the comparators.\"\n\n \n\n \nASTRAZENECA REPORTS TOP-LINE PHASE III KRONOS TRIAL RESULTS FOR PT010 TRIPLE COMBINATION THERAPY IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE\n \nPT010 demonstrates significant improvement in six out of seven lung function primary endpoints compared with dual combination therapies\n \nAstraZeneca today announced top-line results from the Phase III KRONOS trial that showed PT010 (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6µg, using Aerosphere Delivery Technology, in a pressurised metered-dose inhaler or pMDI) demonstrated a statistically significant improvement compared with dual combination therapies in six out of seven 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). In total, eight of the nine primary endpoints in the KRONOS trial were met, including two non-inferiority endpoints to qualify PT009, one of the comparators.\n \nKRONOS is a randomised, double-blind, parallel-group, 24-week, chronic-dosing, multi-centre trial to assess the efficacy and safety of PT010. The trial compared PT010 to Bevespi Aerosphere (glycopyrronium/formoterol fumarate 14.4/9.6µg pMDI), Symbicort Turbuhaler (budesonide/formoterol fumarate 400/12µg) and PT009 (budesonide/formoterol fumarate 320/9.6µg using Aerosphere Delivery Tech...