Tokyo, Japan – 27 November, 2017: Sosei Group Corporation (“Sosei”; TSE: 4565) has confirmed the announcement by Novartis of positive results from the FLASH* study examining the safety and efficacy of directly switching moderate-to-severe symptomatic and non-frequently exacerbating† chronic obstructive pulmonary disease (COPD) patients to Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg1 from Seretide® (salmeterol/fluticasone) 50/500 mcg. The study met the primary endpoint demonstrating that switching patients to Ultibro® Breezhaler® resulted in significantly improved lung function (trough FEV1)1.
The FLASH study is the first randomized controlled trial to confirm the benefits of directly switching patients to the Ultibro® Breezhaler®1 from this widely-used steroid-containing therapy, therefore avoiding the side effects of the long-term use of inhaled corticosteroids. Critically, patients were switched without a wash-out period‡ to mimic clinical practice1. The superiority of once-daily Ultibro® Breezhaler® over twice-daily salmeterol/fluticasone in improving lung function2-3 and reducing the rate of COPD exacerbations4 has been established in previous studies.
The results of the FLASH study 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 types5.
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).