Figures
- FIGURE 1
Least squares (LS) mean change from baseline (95% CI) in trough forced expiratory volume in 1 s (FEV1) according to previous chronic obstructive pulmonary disease medication (intent-to-treat population). ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; BUD: budesonide; FOR: formoterol; LAMA: long-acting muscarinic antagonist; TIO: tiotropium; FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg). a) ICS+LABA, b) BUD+FOR, c) ICS+LABA+LAMA, d) LAMA alone, e) TIO alone and f) LAMA+LABA.
- FIGURE 2
Least squares (LS) mean change from baseline (95% CI) in St George's Respiratory Questionnaire (SGRQ) Total score according to previous chronic obstructive pulmonary disease medication subgroups (intent-to-treat population). ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; BUD: budesonide; FOR: formoterol; LAMA: long-acting muscarinic antagonist; TIO: tiotropium; FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg). a) ICS+LABA, b) BUD+FOR, c) ICS+LABA+LAMA, d) LAMA alone, e) TIO alone and f) LAMA+LABA. The grey line indicates the 4-unit change in SGRQ score considered the minimal clinically important difference.
- FIGURE 3
Least squares (LS) mean change from baseline (95% CI) in trough forced expiratory volume in 1 s (FEV1) according to chronic obstructive pulmonary disease severity (intent-to-treat population). FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg). a) FEV1 % pred <50%, no moderate/severe exacerbations (n=626), b) FEV1 % pred <50%, ≥1 moderate/severe exacerbations (n=589) and c) FEV1 % pred 50– <80%, ≥2 moderate or ≥1 severe exacerbations (n=585).
- FIGURE 4
Least squares (LS) mean change from baseline (95% CI) in St George's Respiratory Questionnaire (SGRQ) Total score according to chronic obstructive pulmonary disease severity (intent-to-treat population). FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg). a) Forced expiratory volume in 1 s (FEV1) % pred <50%, no moderate/severe exacerbations (n=626), b) FEV1 % pred <50%, ≥1 moderate/severe exacerbations (n=589) and c) FEV1 % pred 50– <80%, ≥2 moderate or ≥1 severe exacerbations (n=585). The grey line indicates the 4-unit change in SGRQ score considered the minimal clinically important difference.
- FIGURE 5
Least squares (LS) mean change from baseline (95% CI) in trough forced expiratory volume in 1 s (FEV1) according to exacerbation history (intent-to-treat population). FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg). a) 0/1 moderate exacerbations, b) ≥2 moderate exacerbations and c) ≥1 severe exacerbations.
- FIGURE 6
Least squares (LS) mean change from baseline (95% CI) in St George's Respiratory Questionnaire (SGRQ) Total score according to exacerbation history (intent-to-treat population). FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg). a) 0/1 moderate exacerbations, b) ≥2 moderate exacerbations and c) ≥1 severe exacerbations. The grey line indicates the 4-unit change in SGRQ score considered the minimal clinically important difference.
Tables
- TABLE 1
Distribution of patients within subgroups in the intent-to-treat (ITT) population (which included the extension (EXT) population up to week 24) and the EXT population (up to week 52)
Week 24 (ITT population) Week 52 (EXT population) FF/UMEC/VI BUD/FOR Total FF/UMEC/VI BUD/FOR Total Total patients 911 899 1810 210 220 430 COPD medication class at screening# Patients 705 678 1383 181 171 352 ICS+LABA 268 (29) 259 (29) 527 (29) 72 (34) 68 (31) 140 (33) BUD+FOR 87 (10) 83 (9) 170 (9) 28 (13) 25 (11) 53 (12) ICS+LABA+LAMA 257 (28) 256 (28) 513 (28) 63 (30) 58 (26) 121 (28) LAMA alone 79 (9) 79 (9) 158 (9) 20 (10) 20 (9) 40 (9) TIO alone 65 (7) 67 (7) 132 (7) 15 (7) 16 (7) 31 (7) LAMA+LABA 101 (11) 84 (9) 185 (10) 26 (12) 25 (11) 51 (12) Disease severity Patients 906 894 1800 208 218 426 FEV1 % pred <50%, no moderate/severe exacerbations 311 (34) 315 (35) 626 (35) 62 (30) 71 (32) 133 (31) FEV1 % pred <50%, ≥1 moderate/severe exacerbation 299 (33) 290 (32) 589 (33) 70 (33) 73 (33) 143 (33) FEV1 % pred 50– <80%, ≥2 moderate or ≥1 severe exacerbations 296 (33) 289 (32) 585 (33) 76 (36) 74 (34) 150 (35) Exacerbation history Patients 911 899 1810 210 220 430 0/1 moderate exacerbations 600 (66) 613 (68) 1213 (67) 148 (70) 159 (72) 307 (71) ≥2 moderate exacerbations 311 (34) 286 (32) 597 (33) 62 (30) 61 (28) 123 (29) ≥1 severe exacerbations 185 (20) 200 (22) 385 (21) 58 (28) 57 (26) 115 (27) Data are presented as n or n (%). FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg); COPD: chronic obstructive pulmonary disease; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist; TIO: tiotropium; FEV1: forced expiratory volume in 1 s. #: subgroups are not exclusive (the n-values in the “Patients” row represent the number of patients in any of the categories for the subgroup; patients receiving BUD/FOR are included in the ICS+LABA group and patients receiving TIO alone are included in the LAMA alone group).
- TABLE 2
Mean annual moderate/severe exacerbation rates by subgroup (intent-to-treat (ITT) population; up to week 24)
Subgroup FF/UMEC/VI BUD/FOR Rate reduction % (95% CI) n Rate n Rate Patients 911 899 Prior medication ICS+LABA 266 0.10 258 0.27 63 (29–80)*** BUD+FOR 87 0.05 83 0.10 54 (−74–88) ICS+LABA+LAMA 256 0.28 254 0.53 47 (13–67)* LAMA alone 79 0.12 79 0.23 49 (−42–81) TIO alone 65 0.15 67 0.20 24 (−125–74) LAMA+LABA 100 0.38 83 0.26 −44 (−194–29) Disease severity FEV1 % pred <50%, no moderate/severe exacerbations 311 0.22 315 0.33 33 (−4–57) FEV1 % pred <50%, ≥1 moderate/severe exacerbation 299 0.22 290 0.41 45 (11–66)* FEV1 % pred 50– <80%, ≥2 moderate or ≥1 severe exacerbations 296 0.22 289 0.30 27 (−21–56) Exacerbation history 0/1 moderate exacerbations 599 0.25 609 0.40 36 (11–54)** ≥2 moderate exacerbations 308 0.24 283 0.32 25 (−23–55) ≥1 severe exacerbations 185 0.13 198 0.32 59 (17–80)* FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg); ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist; TIO: tiotropium; FEV1: forced expiratory volume in 1 s. *: p<0.05; **: p<0.01; ***: p<0.005, statistically significant difference for FF/UMEC/VI:BUD/FOR ratio.
Supplementary Material
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Tables S1–S4 00119-2017_supplementary
