Novartis today announced positive results from the FLASH study examining the safety and efficacy of directly switching chronic obstructive pulmonary disease (COPD) patients from Seretide® (salmeterol/fluticasone) 50/500 mcg to Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg. The study met the primary endpoint demonstrating that switching patients to Ultibro Breezhaler resulted in significantly improved lung function (trough FEV1).
The superiority of once-daily Ultibro Breezhaler over twice-daily salmeterol/fluticasone in improving lung function and reducing the rate of COPD exacerbations has been established in previous studies. The FLASH study is the first randomized controlled trial to confirm the benefits of directly switching patients from this steroid-containing therapy to the dual bronchodilator, therefore avoiding the side effects of the long-term use of inhaled corticosteroids. Importantly, patients were switched without a wash-out period to mimic clinical practice.
“It has already been established that Ultibro Breezhaler improves patients’ lung function when directly compared to Seretide in clinical trials,” said Shreeram Aradhye, Chief Medical Officer and Global Head of Medical Affairs for Novartis Pharmaceuticals. “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”.
These results further reinforce the latest GOLD recommendations, which support the use of dual bronchodilation for the majority of symptomatic COPD patients and limit the use of steroid-containing therapies to specific patient types.
Importantly, the data released today also indicated that the safety and tolerability profiles of the two treatments were similar.
The FLASH study results were presented at the Asian Pacific Society of Respirology (APSR) Congress in Sydney, Australia (23-26 November 2017).