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Table 1 Patient demographics and baseline characteristics (ITT population)

From: Once-daily single-inhaler versus twice-daily multiple-inhaler triple therapy in patients with COPD: lung function and health status results from two replicate randomized controlled trials

 Study 207608Study 207609
FF/UMEC/VI
N = 363
BUD/FOR + TIO
N = 365
FF/UMEC/VI
N = 366
BUD/FOR + TIO
N = 366
Age, years, mean (SD)65.4 (7.9)64.9 (8.1)65.5 (8.2)65.1 (8.4)
Female, n (%)180 (50)164 (45)180 (49)179 (49)
BMI, kg/m2, mean28.21 (6.58)28.40 (6.93)28.54 (7.56)28.67 (7.14)
Smoking history and statusn = 363n = 365n = 366n = 366
 Current smoker, n (%)186 (51)168 (46)170 (46)190 (52)
 Smoking pack-years, mean (SD)47.9 (25.3)47.9 (25.7)48.3 (23.8)50.2 (24.6)
COPD typen = 356n = 358n = 362n = 363
 Chronic bronchitis, n (%)139 (38)121 (33)138 (38)146 (40)
 Emphysema, n (%)102 (28)133 (36)118 (32)118 (32)
 Chronic bronchitis and emphysema, n (%)115 (32)104 (28)106 (29)99 (27)
COPD historyn = 363n = 365n = 366n = 365
 Duration of COPD, years, mean (SD)10.5 (6.8)9.9 (6.8)10.4 (7.3)9.7 (7.0)
 < 1 year, n (%)2 (< 1)4 (1)5 (1)4 (1)
 ≥ 1–< 5 years, n (%)69 (19)72 (20)66 (18)75 (20)
 ≥ 5–< 10 years, n (%)123 (34)133 (36)126 (34)152 (42)
 ≥ 10 years, n (%)169 (47)156 (43)169 (46)134 (37)
Moderate COPD exacerbations in the previous 12 months, n (%)n = 363n = 365n = 366n = 366
 0192 (53)191 (52)185 (51)202 (55)
 160 (17)55 (15)67 (18)59 (16)
 ≥ 2111 (31)119 (33)114 (31)105 (29)
Severe COPD exacerbations in the previous 12 months, n (%)n = 363n = 365n = 366n = 366
 0324 (89)325 (89)326 (89)310 (85)
 134 (9)35 (10)37 (10)47 (13)
 ≥ 25 (1)5 (1)3 (< 1)9 (2)
Screening lung function, mean (SD)n = 363n = 364n = 362n = 366
 Post-bronchodilator FEV1 (L)1.176 (0.431)1.199 (0.411)1.128 (0.398)1.181 (0.429)
 Post-bronchodilator FEV1/FVC (% FEV1)0.469 (0.110)0.472 (0.115)0.481 (0.107)0.492 (0.109)
 Post-bronchodilator FEV1, % predicted42.5 (11.9)42.3 (12.3)41.4 (12.5)42.8 (13.0)
 Peak inspiratory flow rate, L/min*208.37 (83.35)200.68 (81.21)191.04 (68.54)195.91 (79.55)
GOLD stage (% predicted FEV1), n (%)n = 363n = 364n = 362n = 366
 Stage I (≥80%)0000
 Stage II (≥ 50 to < 80%)76 (21)82 (23)71 (20)84 (23)
 Stage III (≥ 30 to < 50%)236 (65)226 (62)219 (60)221 (60)
 Stage IV (< 30%)51 (14)56 (15)72 (20)61 (17)
Reversibility to salbutamol, n (%)n = 358n = 360n = 358n = 362
 Reversible65 (18)80 (22)48 (13)55 (15)
CAT score at screening, mean (SD)21.6 (6.5)22.0 (6.6)22.2 (6.3)22.3 (6.4)
COPD medications at screening, n (%)n = 363n = 365n = 366n = 366
 ICS + LABA121 (33)137 (38)123 (34)115 (31)
 ICS + LAMA + LABA113 (31)96 (26)118 (32)116 (32)
 LABA + LAMA55 (15)42 (12)59 (16)67 (18)
 LAMA23 (6)30 (8)26 (7)31 (8)
  1. *207608, FF/UMEC/VI: n = 348; BUD/FOR+TIO: n = 354; 207609, FF/UMEC/VI: n = 342; BUD/FOR+TIO: n = 342. Reversible defined as an increase in FEV1 of ≥ 12% and ≥ 200 mL following administration of salbutamol. 207608, FF/UMEC/VI: n = 359; BUD/FOR+TIO: n = 364; 207609, FF/UMEC/VI: n = 364; BUD/FOR+TIO: n = 360. BMI body mass index; BUD budesonide; CAT COPD Assessment Test; COPD chronic obstructive pulmonary disorder; FEV1 forced expiratory volume in 1 s; FF fluticasone furoate; FOR formoterol; FVC forced vital capacity; GOLD Global Initiative for Chronic Obstructive Lung Disease; ICS inhaled corticosteroid; ITT intent-to-treat; LABA long-acting β2-agonist; LAMA long-acting muscarinic antagonist; SD standard deviation; TIO tiotropium; UMEC umeclidinium; VI vilanterol