Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease
Brief Summary: 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. Published studies which assessed the use of an 'open' triple therapy (use of Inhaled Corticosteroid \[ICS\]/ Long-acting Muscarinic Receptor Antagonists \[LAMA\])/ Long Acting Beta-Agonist \[LABA\] 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. These studies have also shown similar safety profile with dual or monotherapy doses for periods of up to one year. 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). 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. Eligible subjects will be randomized to one of the following double-blind treatment groups FF/UMEC/VI 100 micrograms (mcg)/62.5 mcg/25 mcg once daily (QD), FF/VI 100 mcg/25 mcg QD, or UMEC/VI 62.5 mcg/25 mcg QD


Options:
A: Arm Label: FF/VI 100/25 mcg + UMEC (62.5mcg); Type: EXPERIMENTAL; Interventions: Drug: FF, Drug: VI, Drug: UMEC | Arm Label: FF/VI 100/25 mcg + UMEC (125mcg); Type: EXPERIMENTAL; Interventions: Drug: FF, Drug: VI, Drug: UMEC | Arm Label: FF/VI 100/25 mcg + Placebo; Type: EXPERIMENTAL; Interventions: Drug: FF, Drug: VI, Drug: Placebo | Intervention Type: DRUG; Name: FF; Assigned to Arm(s): FF/VI 100/25 mcg + Placebo, FF/VI 100/25 mcg + UMEC (125mcg), FF/VI 100/25 mcg + UMEC (62.5mcg) | Intervention Type: DRUG; Name: VI; Assigned to Arm(s): FF/VI 100/25 mcg + Placebo, FF/VI 100/25 mcg + UMEC (125mcg), FF/VI 100/25 mcg + UMEC (62.5mcg) | Intervention Type: DRUG; Name: UMEC; Assigned to Arm(s): FF/VI 100/25 mcg + UMEC (125mcg), FF/VI 100/25 mcg + UMEC (62.5mcg) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): FF/VI 100/25 mcg + Placebo
B: Arm Label: UMEC/VI 125/25 mcg; Type: EXPERIMENTAL; Interventions: Drug: UMEC/VI 125/25 mcg | Arm Label: UMEC/VI 62.5/25 mcg; Type: EXPERIMENTAL; Interventions: Drug: UMEC/VI 62.5/25 mcg | Arm Label: UMEC 125 mcg; Type: EXPERIMENTAL; Interventions: Drug: UMEC 125 mcg | Arm Label: UMEC 62.5 mcg; Type: EXPERIMENTAL; Interventions: Drug: UMEC 62.5 mcg | Arm Label: VI 25 mcg; Type: EXPERIMENTAL; Interventions: Drug: VI 25 mcg | Intervention Type: DRUG; Name: UMEC/VI 125/25 mcg; Assigned to Arm(s): UMEC/VI 125/25 mcg | Intervention Type: DRUG; Name: UMEC/VI 62.5/25 mcg; Assigned to Arm(s): UMEC/VI 62.5/25 mcg | Intervention Type: DRUG; Name: UMEC 125 mcg; Assigned to Arm(s): UMEC 125 mcg | Intervention Type: DRUG; Name: UMEC 62.5 mcg; Assigned to Arm(s): UMEC 62.5 mcg | Intervention Type: DRUG; Name: VI 25 mcg; Assigned to Arm(s): VI 25 mcg
C: Arm Label: Active; Type: EXPERIMENTAL; Interventions: Drug: 100mcg | Arm Label: Active 2; Type: EXPERIMENTAL; Interventions: Drug: 500mcg | Arm Label: Active 3; Type: EXPERIMENTAL; Interventions: Drug: 1000mcg | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: 100mcg; Assigned to Arm(s): Active | Intervention Type: DRUG; Name: 500mcg; Assigned to Arm(s): Active 2 | Intervention Type: DRUG; Name: 1000mcg; Assigned to Arm(s): Active 3 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: fluticasone furoate/umeclidinium bromide/vilanterol; Type: EXPERIMENTAL; Interventions: Drug: fluticasone furoate (FF), Drug: vilanterol (VI), Drug: umeclidinium bromide (UMEC) | Arm Label: fluticasone furoate/vilanterol; Type: EXPERIMENTAL; Interventions: Drug: fluticasone furoate (FF), Drug: vilanterol (VI) | Arm Label: umeclidinium bromide/vilanterol; Type: EXPERIMENTAL; Interventions: Drug: vilanterol (VI), Drug: umeclidinium bromide (UMEC) | Intervention Type: DRUG; Name: fluticasone furoate (FF); Assigned to Arm(s): fluticasone furoate/umeclidinium bromide/vilanterol, fluticasone furoate/vilanterol | Intervention Type: DRUG; Name: vilanterol (VI); Assigned to Arm(s): fluticasone furoate/umeclidinium bromide/vilanterol, fluticasone furoate/vilanterol, umeclidinium bromide/vilanterol | Intervention Type: DRUG; Name: umeclidinium bromide (UMEC); Assigned to Arm(s): fluticasone furoate/umeclidinium bromide/vilanterol, umeclidinium bromide/vilanterol

Answer: D