Novartis announced positive first results from the phase III FLAME head-to-head trial examining the rate of chronic obstructive pulmonary disease (COPD) exacerbations. Once-daily Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg met its primary endpoint (non-inferiority) and furthermore demonstrated superiority to twice-daily Seretide (salmeterol/fluticasone) 50/500 mcg in reducing the rate of all COPD exacerbations (mild/moderate/severe) over one year of treatment.
This finding is consistent with the earlier LANTERN trial and is now expanded to patients with at least one exacerbation in the previous year. The safety profiles of the two treatments were consistent with their known profiles, according to the initial FLAME results.
"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," said Vasant Narasimhan, global head of development, Novartis Pharmaceuticals.
"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."
The full FLAME study results, including data from further secondary endpoints, will be reported at an appropriate scientific forum in due course.
FLAME was a randomized, double-blind, parallel-group, non-inferiority, active-controlled 52-week study involving 3,362 COPD patients and conducted at 356 sites across 43 countries. The primary objective of the study was to demonstrate that Ultibro Breezhaler 110/50 mcg was non-inferior to salmeterol/fluticasone (SFC) 50/500 mcg in terms of rate of all COPD exacerbations (mild/moderate/severe) during 52 weeks of treatment.
Secondary endpoints for the study comparing Ultibro Breezhaler to SFC included superiority in terms of rate of all COPD exacerbations over the study duration and efficacy in terms of the following: time to first COPD exacerbation (mild/moderate/severe); rate and time to first moderate-to-severe COPD exacerbation; lung function (trough FEV1); health-related quality of life (as measured by the shortened version of the St George's Respiratory Questionnaire [SGRQ-C]); rescue medication use and safety.
FLAME is the last of 11 studies in the IGNITE phase III clinical trial programme exploring Ultibro Breezhaler for the treatment of COPD.
Ultibro Breezhaler 110/50 mcg is a once-daily LABA/LAMA+ dual bronchodilator approved in the European Union (EU) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Clinical trials have shown that it offers statistically significant improvements in bronchodilation compared to treatments widely used as current standards of care, including SFC 50/500 mcg and open-label tiotropium (18 mcg). Ultibro Breezhaler is currently approved for use in over 70 countries worldwide, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia. In the US the treatment is approved in a twice-daily formulation of indacaterol 27.5 mcg/glycopyrrolate 15.6 mcg, known as Utibron Neohaler.