Novartis has welcomed the concurrent publication and presentation of findings from the FLAME study in the New England Journal of Medicine and at the 2016 American Thoracic Society International Conference in San Francisco.
The results of the study will enhance understanding of the role of dual-bronchodilation (long-acting beta-agonist [LABA] and long-acting muscarinic antagonist [LAMA] combination therapy) in the treatment of patients with chronic obstructive pulmonary disease (COPD) with a history of exacerbation, Novartis says.
It says the study may also help inform treatment guidelines which currently recommend the inclusion of an inhaled corticosteroid (ICS) with a LABA as the recommended first choice for COPD patients at high risk of exacerbation (airflow limitation of FEV1 <50% predicted and ≥ 2 exacerbations or ≥ 1 exacerbation with hospitalisation per year).
Despite recommending the use of an ICS in COPD patients at high risk of exacerbation, the international GOLD (Global Initiative for Chronic Obtrusive Lung Disease) guidelines and Australian Lung Foundation COPD-X guide for primary care note that inhaled corticosteroid therapy is associated with an increased risk of pneumonia.
FLAME is a head-to-head trial that compared the rate of exacerbations (mild / moderate / severe) over a 52 week period among 3,362 COPD patients with one or more exacerbations in the past year were randomized to receive either once-daily Ultibro Breezhaler (LABA / LAMA combination containing indacaterol 110 mcg and glycopyrronium 50 mcg) or twice-daily Seretide (ICS / LABA combination containing fluticasone 500 mcg and salmeterol 50 mcg).