In the current study subjects meeting all inclusion/exclusion criteria will complete 2-week run-in period 52 week treatment period and a 1-week safety follow-up period. Given the clinical experience with FF, UMEC and VI, and that the associated risks with these compounds are anticipated from their known pharmacology, the potential benefit of a new therapy option in patients with moderate to severe COPD supports the further development of the closed triple combination (delivered via one inhaler). These studies have also shown similar safety profile with dual or monotherapy doses for periods of up to one year.
Published studies which assessed the use of an 'open' triple therapy (use of Inhaled Corticosteroid / Long-acting Muscarinic Receptor Antagonists )/ Long Acting Beta-Agonist delivered via multiple inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared to dual therapy (ICS/LABA) or LAMA alone. The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD.
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