Table 1.

Characteristics of studies evaluating triple inhaled therapy with fluticasone furoate, umeclidinium and vilanterol.

Study	Single inhaler	Randomization	Study type	Treatment arms	Number of subjects	Duration	Primary outcome	Secondary outcome and other parameters evaluated
Siler and colleagues study A35	No	Yes	Multicenter	• UMEC (62.5 µg) + FF/VI (100/25 µg) • UMEC (125 µg) + FF/VI (100/25 µg) • Placebo + FF/VI (100/25 µg)	727 COPD patients	12 week	change from baseline in trough FEV1	0–6 h post-dose weighted mean FEV1 at day 84 SGRQ score Adverse events
Siler and colleagues study B35	No	Yes	Multicenter	• UMEC (62.5 µg) + FF/VI • UMEC (125 µg) + FF/VI (100/25 µg) • Placebo + FF/VI (100/25 µg)	730 COPD patients	12 week	Change from baseline in trough FEV1	0–6 h post-dose weighted mean FEV1 at day 84 SGRQ score Adverse events
Brealey and colleagues study A36	Yes	Yes	Single center	• FF/UMEC/VI (400/500/100 µg) FF/VI (400/100 µg) • FF/UMEC (400/500 µg) • UMEC/VI (500/100 µg)	44 healthy subjects	48 h	PK/PD parameters	Adverse events, serious adverse events, laboratory values, vital sign, physical examination
Brealey and colleagues study B36	Yes	Yes	Single center	• FF/UMEC/VI (400/500/100 µg or 400/250/100 µg) • UMEC/VI (250/100 µg) • FF/VI (400/100 µg)	44 healthy subjects	24 h	PK parameters	Adverse events, serious adverse events, laboratory values, vital sign, physical examination
Lipson and colleagues37	Yes	Yes	Multicenter	• FF/UMEC/VI • Budesonide/formeterol	1810 COPD patients	24 weeks A subgroup remained on blinded treatment for up to 52 week	Composite: Change from baseline in trough FEV1 Change from baseline in SGRQ total score	Efficacy and safety, including exacerbation rate, adverse events, pneumonia, cardiovascular events, bone fractures

COPD, chronic obstructive pulmonary disease; FEV₁, forced expiratory volume in 1 s; FF, fluticasone furaoate; PD, pharmacodynamics; PK, pharmacokinetics; SGRQ, St. George’s Respiratory Questionnaire; UMEC, umeclidinium; VI, vilanterol.