Novartis recently announced that the company’s once-a-day Ultibro® Breezhaler® (indacaterol/glycopyrronium), a dual bronchodilator, has meet its primary endpoint in a Phase 3 clinical trial (FLAME trial), showing superior efficacy when compared to twice-a-day Seretide® (salmeterol/fluticasone) in reducing mild, moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations.
The IGNITE Phase 3 clinical trial program, evaluating Ultibro Breezhaler for the treatment of COPD, is composed of 11 individual studies. The last of these studies was the FLAME trial, which involved 3,362 COPD patients in various centers across 43 countries. The primary endpoint of the study was to demonstrate that Ultibro Breezhaler (110/50 mcg) was not inferior to the established medication salmeterol/fluticasone (SFC, 50/500 mcg) in managing all ranges of COPD exacerbations during a 52-week treatment. Secondary objectives included superiority of treatment by Ultibro Breezhaler when compared to SFC, and efficacy in terms of a series of lung function parameters and quality of life evaluations, namely time to first exacerbation, FEV1 (forced expiratory volume in 1 second), safety and health-related quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ-C).
The positive results of FLAME are consistent with previous findings in the LANTERN trial. The study is now expanding to patients with at least one COPD exacerbation in the previous year.
Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals commented the results in a press release, “Today’s FLAME study results provide clear further evidence that Ultibro Breezhaler is more effective than Seretide in reducing COPD exacerbations, events linked to significant patient suffering and more rapid progression of the disease. We believe FLAME challenges our historical reliance on inhaled corticosteroids and may support expanding the use of dual bronchodilators to both exacerbating and non-exacerbating COPD patients.”
This is the first large-scale study to demonstrate that the drug Ultibro Breezhaler, a steroid-free medicine, is effective and safe in reducing exacerbations and improving lung function in COPD patients with a history of past exacerbations in comparison to SFC.
Novartis announced that the complete results of the FLAME study trial will be presented in 2016 in a suitable scientific forum.