Single-inhaler triple therapy in patients with chronic obstructive pulmonary disease: a systematic review

Langham, Sue; Lewis, Jen; Pooley, Nick; Embleton, Nina; Langham, Julia; Han, MeiLan K.; Chalmers, James D.

doi:10.1186/s12931-019-1213-9

Respiratory Research

Table 1 Overview of included studies and study characteristics at baseline

From: Single-inhaler triple therapy in patients with chronic obstructive pulmonary disease: a systematic review

Study	Treatment	Key comparisons	Study length	Number of patients	FEV₁, post-bronchodilator, % of predicted normal value	CAT score		Exacerbation rate (range)	Exacerbations in the previous year			Prior triple therapy^c	Prior ICS	Patients with asthma
Study	Treatment	Key comparisons	Study length	Number of patients	FEV₁, post-bronchodilator, % of predicted normal value	≥10	Mean (SD)	Exacerbation rate (range)	≥1 moderate or severe	≥2 moderate or severe	≥1 severe	Prior triple therapy^c	Prior ICS	Patients with asthma
TRINITY [16]	GLY/FOR/BDP (Trimbow)	Triple therapy (single inhaler) versus TIO^a	52 weeks	2691	36.6%	100%	21.5 (5.8)	1.3 (1–11)	NR	NR	NR	Excluded	77%	Excluded
	TIO				36.6%	100%	21.6 (5.8)	1.3 (1–5)	NR	NR	NR		78%
	FOR/BDP + TIO				36.7%	100%	21.7 (6.0)	1.2 (1–7)	NR	NR	NR		73%
TRILOGY [17]	GLY/FOR/BDP (Trimbow)	Triple therapy versus LABA/ICS	52 weeks	1368	36.9%	100%	20.8 (5.9)	1.2 (1–5)	NR	NR	NR	Excluded	75%	Excluded
TRILOGY [17]	FOR/BDP	Triple therapy versus LABA/ICS	52 weeks	1368	36.2%	100%	20.8 (5.7)	1.2 (1–6)	NR	NR	NR	Excluded	73%	Excluded
TRIBUTE [23]	GLY/FOR/BDP (Trimbow)	Triple therapy versus LAMA/LABA	52 weeks	1532	36.4%	100%	NR	1.2 (1–6)	100%	20%	NR	Excluded	66%	Excluded
TRIBUTE [23]	GLY/IND	Triple therapy versus LAMA/LABA	52 weeks	1532	36.4%	100%	NR	1.2 (1–4)	100%	18%	NR	Excluded	64%	Excluded
FULFIL^b [24]	UMEC/VI/FF (Trelegy Ellipta)	Triple therapy versus LABA/ICS	24 weeks (extension to 52 weeks)	1810 (430)	47.1%	100%	NR	NR	70%	34%	NR	32%	66%	Excluded
FULFIL^b [24]	FOR/B + placebo	Triple therapy versus LABA/ICS	24 weeks (extension to 52 weeks)	1810 (430)	45.4%	100%	NR	NR	67%	31%	NR	33%	67%	Excluded
IMPACT [25, 31]	UMEC/VI/FF (Trelegy Ellipta)	Triple therapy versus LAMA/LABA Triple therapy versus LABA/ICS	52 weeks	10,355	45.7%	100%	20.1 (6.1)	NR	99.95%	55%	26%	38%	72%	Excluded^d
	UMEC/VI				45.4%	100%	20.2 (6.2)	NR	99.90%	55%	25%	40%	72%
	VI/FF				45.5%	100%	20.1 (6.1)	NR	99.88%	54%	26%	38%	70%
KRONOS [26]	GLY/FOR/B	Triple therapy versus LAMA/LABA Triple therapy versus LABA/ICS	24 weeks	1902	NR	100%	18.7 (6.4)	0.4 (0.8)^e 0.0 (0–8)^f	27%	7%	NR	31%	72%	Excluded
	GLY/FOR				NR	100%	18.1 (6.1)	0.3 (0.7)^e 0.0 (0–5)^f	24%	7%	NR	28%	71%
	FOR/B				NR	100%	18.4 (6.6)	0.3 (0.6)^e 0.0 (0–4)^f	25%	6%	NR	34%	71%

B budesonide, BDP beclomethasone, CAT COPD assessment test, COPD chronic obstructive pulmonary disease. FEV₁ forced expiratory volume in one second, FF fluticasone furoate, FOR formoterol fumarate, FULFIL Lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy, GLY glycopyrronium bromide, ICS inhaled corticosteroids, IMPACT InforMing the PAthway of COPD Treatment, IND indacaterol, LABA long-acting β₂ agonist, LAMA long-acting muscarinic antagonist, NR not reported, SD standard deviation, TIO tiotropium, UMEC umeclidinium, VI vilanterol
^aOther comparisons were triple therapy (single inhaler) versus LABA/ICS + LAMA and TIO versus LABA/ICS + LAMA
^b52-week data
^cIncluding LAMA, LAMA and ICS
^dPatients with a prior history of asthma, but not those with a current diagnosis of asthma, were eligible for inclusion
^eMean (SD)
^fMedian (range)

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