Table 1.
Baseline demographics and patient characteristics in the ITT and TDI populations
| FF/UMEC/VI | FF/VI | UMEC/VI | Overall | |
|---|---|---|---|---|
| ITT population [2] | (n = 4151) | (n = 4134) | (n = 2070) | (N = 10,355) |
| Mean age (SD), years | 65.3 (8.2) | 65.3 (8.3) | 65.2 (8.3) | 65.3 (8.3) |
| Male, n (%) | 2766 (67) | 2748 (66) | 1356 (66) | 6870 (66) |
| Former smoker, n (%) | 2715 (65) | 2711 (66) | 1342 (65) | 6768 (65) |
| Baseline CAT score | (n = 4076) | (n = 4047) | (n = 2034) | NA |
| Mean (SD) | 18.2 (6.98) | 18.3 (6.99) | 18.1 (6.88) | NA |
| Baseline SGRQ total score | (n = 4108) | (n = 4092) | (n = 2050) | NA |
| Mean (SD) | 50.8 (16.8) | 50.7 (17.0) | 50.2 (16.7) | NA |
| Baseline pre-bronchodilator % predicted FEV1 | (n = 4144) | (n = 4133) | (n = 2068) | (n = 10,345) |
| Mean (SD) | 41.9 (14.6) | 41.6 (14.4) | 41.8 (14.4) | 41.8 (14.5) |
| Baseline post-bronchodilator % predicted FEV1 | (n = 4145) | (n = 4133) | (n = 2069) | (n = 10,347) |
| Mean (SD) | 45.7 (15.0) | 45.5 (14.8) | 45.4 (14.7) | 45.5 (14.8) |
| GOLD grade, n (%) | (n = 4145) | (n = 4133) | (n = 2069) | (N = 10,347) |
| 1 (mild; % predicted FEV1 ≥ 80) | 10 (< 1) | 8 (< 1) | 4 (< 1) | 22 (< 1) |
| 2 (moderate; ≥ 50% predicted FEV1 < 80) | 1535 (37) | 1455 (35) | 729 (35) | 3719 (36) |
| 3 (severe; ≥ 30% predicted FEV1 < 50) | 1934 (47) | 2031 (49) | 1017 (49) | 4982 (48) |
| 4 (very severe; % predicted FEV1 < 30) | 666 (16) | 639 (15) | 319 (15) | 1624 (16) |
| Exacerbation history in the previous year, n (%) | (n = 4151) | (n = 4134) | (n = 2070) | (N = 10,355) |
| ≥ 1 moderate and no severe | 1198 (29) | 1242 (30) | 616 (30) | 3056 (30) |
| ≥ 2 moderate or ≥ 1 severe | 2953 (71) | 2892 (70) | 1454 (70) | 7299 (70) |
| TDI population* | (n = 2029) | (n = 2014) | (n = 1015) | (N = 5058) |
| Mean age (SD), years | 64.6 (8.2) | 64.8 (8.3) | 64.5 (8.3) | 64.7 (8.3) |
| Male, n (%) | 1151 (57) | 1134 (56) | 571 (56) | 2856 (56) |
| Mean BDI (SD) | 5.9 (1.9) | 5.9 (2.0) | 5.9 (2.0) | NA |
BDI Baseline Dyspnea Index, CAT COPD (chronic obstructive pulmonary disease) Assessment Test, FEV1 forced expiratory volume in 1 s, FF fluticasone furoate, GOLD Global Initiative for Chronic Obstructive Lung Disease, ITT intent to treat, NA not available (not measured at screening), SD standard deviation, SGRQ St George’s Respiratory Questionnaire, TDI Transitional Dyspnea Index, UMEC umeclidinium, VI vilanterol
*BDI/TDI data were only collected for a subset of patients at sites in Belgium, Canada, the Czech Republic, Denmark, Germany, The Netherlands, Poland, Spain, the UK, and the USA where approved translations of the questionnaire existed