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ARTICLE | Clinical News

Breo Ellipta: Phase III data

September 14, 2015 7:00 AM UTC

The double-blind, international Phase III SUMMIT trial in 16,485 COPD patients with moderate airflow limitation (50-70% predicted FEV1) and a history or risk of cardiovascular disease showed that once-daily 100/25 ug Breo Ellipta missed the primary endpoint of reducing all-cause mortality vs. placebo. Specifically, Breo Ellipta reduced the risk of death by 12.2% vs. placebo (p=0.137). On secondary endpoints, Breo Ellipta reduced the rate of lung function decline as measured by FEV1 by 8 mL/year vs. placebo (p=0.019) and reduced the risk of experiencing a composite of on-treatment death, MI, stroke, unstable angina or transient ischemic attack by 7.4% vs. placebo (p=0.475). For the secondary FEV1 endpoint, GSK and Theravance said statistical significance could not be inferred because the primary endpoint was not met. Patients were allowed to use study-supplied albuterol/salbutamol. If patients experienced multiple moderate COPD exacerbations or a severe COPD exacerbation during the trial, a long-acting muscarinic antagonist (LAMA) or phosphodiesterase-4 (PDE-4) inhibitor was allowed. Oral corticosteroids and antibiotics were also allowed for the short-term treatment of COPD exacerbations. Patients were also allowed to continue taking cardiovascular medications throughout the trial and use of any inhaled corticosteroid or LABA was not allowed. This month, data will be presented at the European Respiratory Society meeting in Amsterdam. ...