Table 1.
Summary of patient demographics and baseline characteristics (ITT population)
| UMEC/VI 62.5/25 μg (n=248) |
PBO (n=248) |
|
|---|---|---|
| Age, years | 64.1 (8.70) | 62.6 (8.23) |
| Male, n (%) | 144 (58) | 149 (60) |
| Current smoker at screening,a n (%) | 137 (55) | 129 (52) |
| Smoking pack-yearsb | 38.82 (20.44) | 38.40 (22.55) |
| ICS use at screening,c n (%) | 111 (45) | 124 (50) |
| Post-albuterol % predicted FEV1 | 46.5 (12.81) | 48.4 (14.06) |
| Post-albuterol FEV1/FVC | 47.81 (10.93) | 49.75 (11.23) |
| Reversible to albuterol,d,e n (%) | 55 (22) | 54 (22) |
| Reversibility to albuterol,e % | 11.5 (15.28) | 10.8 (13.49) |
| % Rescue-free days,f mean (SD) | 20.4 (34.54) | 23.5 (35.94) |
| Rescue albuterol use, puffs/day,f mean (SD) | 3.8 (3.32) | 3.4 (3.57) |
| SGRQ score at baseline,g mean (SD) | 48.14 (17.08) | 47.58 (17.25) |
| GOLD category, n (%) | ||
| GOLD B | 90 (36) | 109 (44) |
| GOLD D | 158 (64) | 139 (56) |
Notes: Values are reported as mean (SD) unless otherwise stated.
Reclassified: subject reclassified as current smoker if smoked within 6 months.
Smoking pack-years = (number of cigarettes smoked per day/20) × number of years smoked.
ICS use was defined as those patients who were currently taking ICS-containing medications at the screening visit.
Reversibility was defined as an increase in FEV1 of ≥12% and ≥200 mL following administration of albuterol.
UMEC/VI 62.5/25 μg, n=247; PBO, n=247.
UMEC/VI 62.5/25 μg, n=244; PBO, n=247.
UMEC/VI 62.5/25 μg, n=239; PBO, n=236.
Abbreviations: FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; GOLD, Global initiative for chronic Obstructive Lung Disease; ICS, inhaled corticosteroid; ITT, intent-to-treat; PBO, placebo; SD, standard deviation; SGRQ, St George’s Respiratory Questionnaire; UMEC, umeclidinium; VI, vilanterol.