Effect of Recent Exacerbation History on the Efficacy of Once-Daily Single-Inhaler Fluticasone Furoate/Umeclidinium/Vilanterol Triple Therapy in Patients with Chronic Obstructive Pulmonary Disease in the FULFIL Trial

Figures & data

Table 1 Baseline Characteristics of the ITT Population

Characteristics	FF/UMEC/VI (N=911)	BUD/FOR (N=899)	Total (N=1810)
Age, years, mean (SD)	64.2 (8.6)	63.7 (8.7)	63.9 (8.6)
Female, n (%)	233 (26)	236 (26)	469 (26)
BMI, kg/m^2, mean (SD)^a,b	26.9 (5.2)	27.0 (5.1)	26.9 (5.1)
Current smokers, n (%)^b	400 (44)	394 (44)	794 (44)
Smoking history, pack-years, mean (SD)	39.5 (21.9)	39.2 (22.2)	39.4 (22.0)
Moderate/severe exacerbations in past year, n (%)
0	313 (34)	317 (35)	630 (35)
1	252 (28)	253 (28)	505 (28)
≥2	346 (38)	329 (37)	675 (37)
Severe exacerbations in past year, n (%)
0	726 (80)	699 (78)	1425 (79)
1	167 (18)	177 (20)	344 (19)
≥2	18 (2)	23 (3)	41 (2)
Post-bronchodilator FEV1, % predicted, mean (SD)^a	45.5 (13.0)	45.1 (13.6)	45.3 (13.3)
SGRQ total score, mean (SD)^c	51.8 (16.3)	50.8 (16.7)	N/A
Eosinophils, 10^9/L, mean (SD)^b,d	0.213 (0.191)	0.213 (0.280)	N/A

Notes: ^aFF/UMEC/VI n=908, BUD/FOR n=897, total n=1805. ^bAt screening. ^cFF/UMEC/VI n=904, BUD/FOR n=893. ^dFF/UMEC/VI n=887, BUD/FOR n=873, total n=1804.

Abbreviations: BUD, budesonide; FEV₁, forced expiratory volume in 1 second; FF, fluticasone furoate; FOR, formoterol; N/A, not available; SD, standard deviation; SGRQ, St George’s respiratory questionnaire; UMEC, umeclidinium; VI, vilanterol.

Table 2 Baseline Characteristics of the ITT Population by Recent Exacerbation Subgroup

Characteristic	Recent Exacerbation^a			No Recent Exacerbation^a
	FF/UMEC/VI (n=598)	BUD/FOR (n=582)	Total (n=1180)	FF/UMEC/VI (n=313)	BUD/FOR (n=317)	Total (n=630)
Age, years, mean (SD)	64.0 (8.9)	63.2 (9.3)	63.6 (9.1)	64.7 (7.9)	64.5 (7.6)	64.6 (7.7)
Female, n (%)	170 (28)	162 (28)	332 (28)	63 (20)	74 (23)	137 (22)
BMI, kg/m^2, mean (SD)^b,c	27.3 (5.1)	27.0 (4.9)	27.2 (5.0)	26.0 (5.2)	26.9 (5.5)	26.5 (5.4)
CAT score, mean (SD)^b	19.1 (5.1)	19.2 (5.3)	19.2 (5.2)	19.3 (5.4)	18.8 (5.1)	19.0 (5.3)
Pre-bronchodilator FEV1, mL, mean (SD)^d	1373 (477)	1353 (498)	1364 (487)	1044 (313)	1032 (294)	1038 (303)
Post-bronchodilator FEV1, % predicted, mean (SD)^e	49.5 (13.2)	48.9 (14.6)	49.2 (13.9)	37.7 (8.2)	38.1 (7.9)	37.9 (8.0)
Eosinophil count, 10^9 cells/L, mean (SD)^b,f	0.212 (0.184)	0.220 (0.333)	0.216 (0.267)	0.216 (0.202)	0.199 (0.151)	0.207 (0.178)

Notes: ^aIn the year prior to study entry. ^bAt screening. ^cRecent exacerbation FF/UMEC/VI n=595, BUD/FOR n=580; total n=1175; no recent exacerbation FF/UMEC/VI n=313, BUD/FOR n=317, total n=630. ^dRecent exacerbation FF/UMEC/VI n=597, BUD/FOR n=582; total n=1179; no recent exacerbation FF/UMEC/VI n=312, BUD/FOR n=317, total n=629. ^eRecent exacerbation FF/UMEC/VI n=596, BUD/FOR n=581; total n=1177; no recent exacerbation FF/UMEC/VI n=312, BUD/FOR n=316, total n=628. ^fRecent exacerbation FF/UMEC/VI n=582, BUD/FOR n=560; total n=1142; no recent exacerbation FF/UMEC/VI n=305, BUD/FOR n=313, total n=618.

Abbreviations: BMI, body mass index; BUD, budesonide; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; FEV₁, forced expiratory volume in 1 second; FF, fluticasone furoate; FOR, formoterol; SD, standard deviation; UMEC, umeclidinium; VI, vilanterol.

Table 3 On-Treatment Moderate/Severe and Severe Exacerbations of the ITT Population by Recent Exacerbation Subgroup

	Recent Exacerbation^a			No Recent Exacerbation^a
	FF/UMEC/VI (n=598)	BUD/FOR (n=582)	Total (n=1180)	FF/UMEC/VI (n=313)	BUD/FOR (n=317)	Total (n=630)
On-treatment moderate/severe exacerbations, n (%)	58 (10)	75 (13)	133 (11)	37 (12)	51 (16)	88 (14)
On-treatment severe exacerbations, n (%)	7 (1)	14 (2)	21 (2)	5 (2)	8 (3)	13 (4)

Note: ^aIn the year prior to study entry.

Abbreviations: BUD, budesonide; FF, fluticasone furoate; FOR, formoterol; UMEC, umeclidinium; VI, vilanterol.

Figure 1 Rate of on-treatment moderate/severe exacerbations up to Week 24 by recent exacerbation subgroup. ^aPre-specified. ^bIn the year prior to study entry. ^cPost hoc.

Abbreviations: BUD, budesonide; CI, confidence interval; FF, fluticasone furoate; FOR, formoterol; ITT, intent-to-treat; UMEC, umeclidinium; VI, vilanterol.

Figure 2 Rate of on-treatment severe exacerbations up to Week 24 by recent exacerbation subgroup. ^aPost hoc. ^bIn the year prior to study entry.

Abbreviations: BUD, budesonide; CI, confidence interval; FF, fluticasone furoate; FOR, formoterol; ITT, intent-to-treat; UMEC, umeclidinium; VI, vilanterol.

Figure 3 Change from baseline in trough FEV₁ at Week 24 by recent exacerbation subgroup. ^aPre specified. ^bIn the year prior to study entry. ^cPost hoc.

Abbreviations: BUD, budesonide; CI, confidence interval; FEV₁, forced expiratory volume in1 second; FF, fluticasone furoate; FOR, formoterol; ITT, intent-to-treat; LS, least-squares; UMEC, umeclidinium; VI, vilanterol.