FLAME is a randomized, double-blind, double-dummy, parallel-group, non-inferiority, active-controlled 52-week study involving 3,362 COPD patients and conducted at 356 sites across 43 countries.
New analyses from the head-to-head FLAME study confirmed that Ultibro® Breezhaler® is a more effective option for patients at risk of chronic obstructive pulmonary disease (COPD) flare-ups (exacerbations) than Seretide®, across different patient sub-groups[1-10]. These findings are being presented at the 2016 European Respiratory Society (ERS) International Congress this week in London, UK.
In the new analyses, once-daily Ultibro Breezhaler 110/50 mcg demonstrated consistent reductions in the rate of all exacerbations (mild, moderate and severe), regardless of age, smoking status, exacerbation history, disease severity, eosinophil levels (a type of white blood cells) and previous inhaled corticosteroid (ICS) use, versus twice-daily Seretide 50/500 mcg. Specifically, among patients with the severest forms of COPD, Ultibro Breezhaler significantly reduced the rate of exacerbations and improved their health status versus the commonly used ICS/LABA combination. In addition, patients using Ultibro Breezhaler needed less rescue medication during the day.
“Earlier this year, the results from our major FLAME study demonstrated that Ultibro Breezhaler is superior to Seretide in reducing exacerbations and improving lung function,” said Vasant Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis. “These new analyses of the data show the consistency of these findings across different patient sub-groups, including a post-hoc analysis in those previously using a triple therapy containing an ICS. This, combined with its safety profile, supports Ultibro Breezhaler as a suitable steroid-free treatment option for COPD patients at risk of exacerbation.”
New analyses presented at ERS 2016 also showed that, compared to Seretide, Ultibro Breezhaler was associated with fewer systemic effects, namely impairment of adrenal function, which regulates the natural production of hormones. Ultibro Breezhaler use has previously shown to be associated with significantly fewer cases of pneumonia than the ICS/LABA combination.
Adding evidence to the need to reduce the risks of chronic ICS therapy, results of a large retrospective observational study involving >87,000 participants (with and without COPD) from Sweden are also being shared at ERS 2016. The ARCTIC study found that COPD patients were at greater risk of pneumonia than those without the disease, but that this risk was even higher for those taking an ICS (whether at a low or high dose). Even people without COPD that took an ICS increased their risk of pneumonia, further demonstrating their interrelationship.
Novartis is presenting over 35 abstracts from across its broad respiratory portfolio at ERS 2016. The company is committed to continual clinical and patient-led research to address the evolving unmet needs of people living with respiratory diseases.