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First three Phase III studies positive for QVA 149 (Novartis)in COPD

Read time: 1 mins
Last updated: 1st Apr 2012
Published: 1st Apr 2012
Source: Pharmawand
The first three Novartis QVA149 (indacaterol 110 mcg/glycopyrronium bromide 50 mcg) Phase III studies in the treatment of chronic obstructive pulmonary disease (COPD) all met their primary endpoints. The SHINE, BRIGHT and ENLIGHTEN studies, which are key components of the IGNITE program, demonstrate the potential of QVA149 in the treatment of COPD.The results of SHINE, with an enrollment of more than 2,100 patients, met the primary endpoint by demonstrating the superiority in trough FEV1 (p<0.001) of once-daily qva149 compared to once-daily indacaterol or once-daily nva237 in patients with moderate to severe copd. in addition qva149 showed superiority in trough fev1 p><0.001) compared to placebo and open-label tiotropium 18 mcg. the results of bright demonstrated that patients experienced significantly better exercise endurance versus placebo p="0.006)." enlighten demonstrated that qva149 was well tolerated with a safety and tolerability profile similar to placebo.see qva149 a2303 shine. clinicaltrials.gov identifier: nct01202188. qva149 a2307 enlighten. clinicaltrials.gov identifier: nct01120717. qva149 2305 bright.clinicaltrials.gov identifier: nct01294787>
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