Once daily Onbrez Breezhaler non inferior to twice daily Seretide for COPD - Novartis

Novartis announced top-line results from the Phase IV INSTEAD switch study in patients with Chronic Obstructive Pulmonary Disease (COPD), which met its primary objective. Once-daily Onbrez Breezhaler (indacaterol) 150 mcg demonstrated non-inferiority in lung function at week 12 to twice-daily Seretide (salmeterol/fluticasone propionate (SFC)) 50/500 mcg in patients with moderate COPD and no exacerbations in the previous year. The INSTEAD switch study also showed similar symptomatic benefits in terms of shortness of breath and health status after 12 and 26 weeks in patients treated with Onbrez Breezhaler compared to those on SFC. The safety profile of Onbrez Breezhaler observed in this study was consistent with previously reported results from Phase III studies.

INSTEAD was a global, randomized, double-blind, parallel-group, 26-week study. This study randomized 581 patients with moderate COPD who had been taking SFC for at least three months to either continue on SFC or switch to indacaterol. The primary objective of this study was to demonstrate the non-inferiority of indacaterol versus SFC in lung function (trough FEV1) after 12 weeks of treatment in patients with moderate COPD who had experienced no exacerbations in the previous year. Data from this study are expected to be presented at major medical congresses later this year.