Novartis announced top-line results from the Phase 4 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 Breezhalerobserved in this study was consistent with previously reported results from Phase 3 studies.
“These positive results help inform the switch from salmeterol/fluticasone to Onbrez Breezhaler in patients with moderate COPD and who are at low risk of exacerbations. This confirms that Onbrez Breezhalerprovides an effective maintenance treatment option for these patients,” said Tim Wright, global head of development, Novartis Pharmaceuticals. “In addition, these results support international guidelines, which advise against the use of inhaled corticosteroids due to long-term risks in COPD patients at low risk of exacerbations.”
COPD affects an estimated 210 million people worldwide and is projected to be the third leading cause of death by 2020. Treatments that effectively control the symptoms of COPD and allow patients to continue with their daily activities are very important in helping address the unmet needs in the management of COPD.
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 indacaterolversus 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.
Date: April 25, 2014