A study published by the New England Journal of Medicine (NEJM) of the head-to-head FLAME study [The study was funded by Novartis Pharmaceuticals], compared the efficacy of once-daily LABA-LAMA (indacaterol/glycopyrronium bromide) 110/50 mcg to twice-daily ICS-LABA (salmeterol/fluticasone [SFC]) 50/500 mcg in reducing chronic obstructive pulmonary disease (COPD) exacerbations.

In addition to meeting the primary endpoint (non-inferiority), findings demonstrated the superiority of LABA-LAMA Dual Bronchodilator over the widely used ICS-LABA combination on exacerbation outcomes. The published FLAME results are anticipated to impact the future management and treatment of COPD patients.

Preventing exacerbations is one of the primary goals of long-term care for COPD patients. These episodes have a detrimental effect on quality of life and disease progression, contributing to further lung function decline and, in severe cases, hospitalization and even death.

Speaking on the study Dr. Ashok Mahasur, Senior Pulmonologist said, “Reducing exacerbations in COPD patients is paramount to improve patient outcomes and quality of life. The superiority of once daily LABA/LAMA dual bronchodilator combination to the currently used inhaled corticosteroid has been proved and is also more effective in reducing COPD exacerbations. This is expected to change all available standard of care which is of great news for COPD patients in India.”

The results of FLAME confirmed that LABA-LAMA dual bronchodilator is superior to ICS-LABA in reducing exacerbation outcomes regardless of a patient’s disease severity and eosinophil levels (a type of white blood cell). Significantly, compared to ICS-LABA, LABA-LAMA dual bronchodilator both reduced the rate of moderate or severe exacerbations with a 17% risk reduction (rate ratio, 0.83), and prolonged the time to the first of these episodes with a 22% risk reduction (hazard ratio, 0.78).

The safety profiles of the two treatments were consistent with their known profiles. The incidence of pneumonia was higher with ICS-LABA than LABA-LAMA dual bronchodilator (4.8% vs 3.2%: a statistically significant difference).

These data were also presented to the scientific community at the 2016 Annual Meeting of American Thoracic Society (ATS) in San Francisco, USA.

FLAME was 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. India participated in the FLAME Study across 12 sites (4 Medical Colleges & 8 Multispecialty Hospitals).

FLAME is part of the IGNITE phase III clinical trial programme exploring indacaterol/glycopyrronium bromide for the treatment of COPD.

Chronic obstructive pulmonary disease (COPD) affects an estimated 210 million people worldwide and is the third leading cause of death. It is progressive (usually gets worse over time), and can be a life-threatening disease. COPD makes it difficult to breathe, with symptoms that have a destructive impact on patients’ function (i.e. activity limitation, decreased mobility) and quality of life.

Exacerbations (disease flare-ups) are a sudden worsening of COPD symptoms that can be “frightening” for patients, causing distress, anxiety and the deterioration of quality of life. COPD exacerbations are also associated with significant healthcare resource burden and costs, particularly due to the frequent need for hospitalization. Consequently, the prevention of exacerbations is an important goal in COPD management to improve long-term health status and conserve healthcare resources.