Novartis has announced that the FLASH study met its primary endpoint, demonstrating that switching COPD patients from Seretide (Advair) salmeterol/fluticasone Ultibro Breezhaler (Utibron Neohaler) indacaterol/glycopyrronium significantly improved lung function. The safety and tolerability of both inhalers was found to be similar.
The 12-week FLASH study enrolled 502 patients with moderate-to-severe COPD. Patients were switched directly from Seretide to Ultibro Breezhaler with no washout period.
Novartis Pharmaceuticals Chief Medical Officer and Global Head of Medical Affairs Shreeram Aradhye commented, “It has already been established that Ultibro Breezhaler improves patients’ lung function when directly compared to Seretide in clinical trials. This new research is important because it shows that this benefit also exists when directly switching patients from Seretide to Ultibro Breezhaler as would happen in everyday clinical practice. The FLASH study provides further evidence that it is possible to reduce the burden of long-term inhaled steroids in many COPD patients, as recommended by global treatment guidelines.”
Ultibro Breezhaler was approved in Europe in 2013. The FDA approved the Utibron Neohaler in 2015.
Read the Novartis press release.