ERS 2016: Data from the FLAME study will allow Ultibro to compete directly with Advair in patients at risk of COPD exacerbations.
By Christina Vasiliou, Senior Analyst
19 September 2016
I joined Datamonitor Healthcare in early 2014, having completed an MPhil in Bioscience Enterprise at the University of C...
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Posters and oral presentations on the FLAME study sponsored by Novartis at the 2016 European Respiratory Society (ERS) International Congress support Ultibro’s (indacaterol/glycopyrrolate bromide; Novartis/Pfizer) use in chronic obstructive pulmonary disease (COPD) patients with high risk of exacerbation. Datamonitor Healthcare believes that data from this 52-week, multicenter, double-blind Phase III study will boost Ultibro’s likelihood of directly competing with GlaxoSmithKline’s Advair (fluticasone/salmeterol) and potentially other inhaled corticosteroid/long-acting beta agonist combination therapies for the position of the preferred intervention for patients at risk of exacerbations. The FLAME study showed that treatment with Ultibro once-daily resulted in a lower rate of all (mild, moderate, severe) exacerbations compared to treatment with Advair twice-daily across patients subgroups defined by age, smoking status, exacerbation history, and disease severity. Ultibro also reduced the rate of moderate or severe exacerbations in all subgroups, except for patients aged below 55 with very severe COPD, though it was noted that the patient numbers in these subgroups were small.
Additional analysis from the FLAME study showed a significant reduction in mean daily rescue medication use with Ultibro versus Advair (least squares mean [LSM] change of daily number of puffs from baseline: -1.01 versus -0.76, respectively), as well as an increase in mean days without rescue medication in patients with moderate-to-very severe COPD (LSM change from baseline: 13.0% versus 8.3%, respectively). Treatment with Ultibro also led to a statistically significant improvement in health status in severe to very severe COPD patients from week 12 onwards compared to twice-daily Advair, as measured by St George’s Respiratory Questionnaire for COPD patients (SGRQ-C) total scores. Furthermore, a higher proportion of patients in the Ultibro group achieved a clinically meaningful improvement in SGRQ-C total score compared to Advair.
Datamonitor Healthcare attended ERS 2016, which explored the current respiratory landscape, and had a strong focus on the development programs of new dual bronchodilator therapies, triple combination therapies, and novel biologics.
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