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/VIBUD/FORTotalFF/UMEC/VIBUD/FORTotal
Total patients9118991810210220430
COPD medication class at screening#
 Patients7056781383181171352
 ICS+LABA268 (29)259 (29)527 (29)72 (34)68 (31)140 (33)
 BUD+FOR87 (10)83 (9)170 (9)28 (13)25 (11)53 (12)
 ICS+LABA+LAMA257 (28)256 (28)513 (28)63 (30)58 (26)121 (28)
 LAMA alone79 (9)79 (9)158 (9)20 (10)20 (9)40 (9)
 TIO alone65 (7)67 (7)132 (7)15 (7)16 (7)31 (7)
 LAMA+LABA101 (11)84 (9)185 (10)26 (12)25 (11)51 (12)
Disease severity
 Patients9068941800208218426
 FEV1 % pred <50%, no moderate/severe exacerbations311 (34)315 (35)626 (35)62 (30)71 (32)133 (31)
 FEV1 % pred <50%, ≥1 moderate/severe exacerbation299 (33)290 (32)589 (33)70 (33)73 (33)143 (33)
 FEV1 % pred 50– <80%, ≥2 moderate or ≥1 severe exacerbations296 (33)289 (32)585 (33)76 (36)74 (34)150 (35)
Exacerbation history
 Patients9118991810210220430
 0/1 moderate exacerbations600 (66)613 (68)1213 (67)148 (70)159 (72)307 (71)
 ≥2 moderate exacerbations311 (34)286 (32)597 (33)62 (30)61 (28)123 (29)
 ≥1 severe exacerbations185 (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).