Figures
- FIGURE 1
Number of combined moderate or severe COPD exacerbations per patient by prior exacerbation subgroup. The exacerbation history subgroups are defined as single moderate (1 moderate/no severe exacerbation in the prior year), frequent moderate (≥2 moderate/no severe exacerbations in the prior year) and severe (≥1 severe/any moderate exacerbation in the prior year). FF: fluticasone furoate; UMEC: umeclidinium; VI: vilanterol.
- FIGURE 2
Annual rate of on-treatment a) moderate or severe and b) severe exacerbations (post-hoc analysis) according to exacerbation history in the year prior to screening for each treatment comparison. The exacerbation history subgroups are defined as single moderate (1 moderate/no severe exacerbation in the prior year), frequent moderate (≥2 moderate/no severe exacerbations in the prior year) and severe (≥1 severe/any moderate exacerbation in the prior year). Data are presented as model estimated annual rate (95% CI), unless otherwise stated. FF: fluticasone furoate; RR: rate ratio; UMEC: umeclidinium; VI: vilanterol.
- FIGURE 3
Time-to-first combined a) moderate or severe and b) severe COPD exacerbations (post-hoc analysis) by treatment by prior exacerbation subgroup for each treatment comparison. The exacerbation history subgroups are defined as single moderate (1 moderate/no severe exacerbation in the prior year), frequent moderate (≥2 moderate/no severe exacerbations in the prior year) and severe (≥1 severe/any moderate exacerbation in the prior year). Data are presented as patients with events n/N (%), unless otherwise stated. FF: fluticasone furoate; UMEC: umeclidinium; VI: vilanterol.
- FIGURE 4
Annual rate of moderate or severe exacerbations, by baseline blood eosinophil count and individual treatment group by prior exacerbation subgroup: a) single moderate, b) frequent moderate and c) severe. The exacerbation history subgroups are defined as single moderate (1 moderate/no severe exacerbation in the prior year), frequent moderate (≥2 moderate/no severe exacerbations in the prior year) and severe (≥1 severe/any moderate exacerbation in the prior year). FF: fluticasone furoate; UMEC: umeclidinium; VI: vilanterol.
- FIGURE 5
Between-treatment differences of a, c, e) FF/UMEC/VI versus UMEC/VI and b, d, f) FF/VI versus UMEC/VI in rates of moderate or severe exacerbations, by baseline blood eosinophil count and prior exacerbation subgroup: a, b) single moderate, c, d) frequent moderate, e, f) severe. The exacerbation history subgroups are defined as single moderate (1 moderate/no severe exacerbation in the prior year), frequent moderate (≥2 moderate/no severe exacerbations in the prior year) and severe (≥1 severe/any moderate exacerbation in the prior year). FF: fluticasone furoate; UMEC: umeclidinium; VI: vilanterol.
- FIGURE 6
LS mean (95% CI) change in St George's Respiratory Questionnaire (SGRQ) at week 52 by prior exacerbation subgroup. The exacerbation history subgroups are defined as single moderate (1 moderate/no severe exacerbation in the prior year), frequent moderate (≥2 moderate/no severe exacerbations in the prior year) and severe (≥1 severe/any moderate exacerbation in the prior year). Post hoc analysis. Data presented as between-treatment difference (95% CI) in LS mean change from baseline at week 52 in SGRQ total score for FF/UMEC/VI versus UMEC/VI, FF/UMEC/VI versus FF/VI and UMEC/VI versus FF/VI. FF: fluticasone furoate; LS: least squares; UMEC: umeclidinium; VI: vilanterol. *: p<0.05.
Tables
- TABLE 1
Baseline demographics according to exacerbation history in the year prior to screening
Subgroup Single moderate Frequent moderate Severe Subjects 3056 (30) 4628 (45) 2671 (26) Age years 65.2±7.95 65.3±8.46 65.4±8.29 Male 2069 (68) 2922 (63) 1879 (70) White 2408 (79) 3604 (78) 1971 (74) Former smoker 1964 (64) 3014 (65) 1790 (67) BMI kg·m−2 26.10±6.043 27.03±5.833 26.52±6.532 Lung function post-bronchodilator At screening FEV1 L 1.046±0.3193 1.437±0.5036 1.247±0.5037 FEV1 % predicted 37.0±8.85 51.9±14.77 44.4±15.25 FEV1/FVC ratio 0.421±0.1028 0.510±0.1161 0.458±0.1201 Baseline# concomitant COPD medication at screening alone or in combination LAMA 243 (8) 375 (8) 213 (8) LABA 84 (3) 166 (4) 41 (2) LAMA+LABA 327 (11) 392 (8) 215 (8) ICS+LABA 906 (30) 1694 (37) 741 (28) ICS+LAMA+LABA 1258 (41) 1651 (36) 1274 (48) Baseline blood eosinophil counts 203±186 230±256 232±242 Patients with count % <100 26 25 24 100–300 55 53 52 >300 19 23 23 Date are presented as n (%) or mean±sd, unless otherwise stated. The exacerbation history subgroups are defined as single moderate (1 moderate/no severe exacerbation in the prior year), frequent moderate (≥2 moderate/no severe exacerbations in the prior year) and severe (≥1 severe/any moderate exacerbation in the prior year). BMI: body mass index; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist. #: between day of screening −3 days and date of screening (inclusive).
- TABLE 2
Patients with ≥1 moderate, ≥1 severe and ≥1 moderate or severe on-treatment exacerbations during the study period by exacerbation history in the year prior to screening
Exacerbation history subgroups On-treatment COPD exacerbations Moderate only Severe only Moderate or severe FF/UMEC/VI Single moderate 486 (41) 708.1 [750] 112 (9) 121.8 [129] 545 (45) 829.9 [879] Frequent moderate 797 (43) 805.4 [1368] 117 (6) 77.7 [132] 859 (46) 883.1 [1500] Severe 436 (40) 783.7 [750] 218 (20) 312.4 [299] 555 (51) 1096.1 [1049] FF/VI Single moderate 542 (44) 857.8 [870] 108 (9) 135.1 [137] 605 (49) 992.9 [1007] Frequent moderate 799 (44) 882.2 [1384] 120 (7) 89.2 [140] 847 (46) 971.4 [1524] Severe 454 (42) 914.4 [800] 233 (22) 348.6 [305] 587 (55) 1263.0 [1105] UMEC/VI Single moderate 252 (41) 849.1 [429] 55 (9) 120.7 [61] 281 (46) 969.9 [490] Frequent moderate 430 (46) 1002.1 [790] 96 (10) 145.9 [115] 478 (51) 1147.9 [905] Severe 205 (40) 958.8 [388] 121 (23) 410.2 [166] 277 (54) 1369.0 [554] Data are presented as n (%) or rate [number of events]. Rate is reported per 1000 subject-years, calculated as the number of events×1000, divided by the total duration at risk. The exacerbation history subgroups are defined as single moderate (1 moderate/no severe exacerbation in the prior year), frequent moderate (≥2 moderate/no severe exacerbations in the prior year) and severe (≥1 severe/any moderate exacerbation in the prior year). FF: fluticasone furoate; UMEC: umeclidinium; VI: vilanterol.
Supplementary Material
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