Phase III
Novartis, announced data from the 52-week pivotal phase III PALLADIUM clinical trial which demonstrated that QMF149, a once-daily fixed-dose combination of indacaterol acetate and mometasone furoate (IND/MF) in development, was superior to mometasone furoate (MF) at medium and high doses in improving lung function, meeting the primary endpoint. Statistically significant superiority compared to MF alone was also demonstrated in the key secondary endpoint of improvement in asthma control. Other secondary analyses of efficacy endpoints showed improvements in lung function when comparing IND/MF to a LABA/ICS standard-of-care (salmeterol xinafoate/fluticasone propionate – SFC). Safety findings were generally comparable among treatment groups and consistent with the known safety profile of the monocomponents. PALLADIUM is part of PLATINUM, the Novartis phase III clinical development program supporting the development of QVM149 and QMF149. These key results were presented at the British Thoracic Society Winter Meeting, in London, UK, and will be submitted for publication in a scientific journal.
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