Table 1.
Patient demographics and baseline clinical characteristics, by disease severity and treatment (3-month data set: Calverley et al, Szafranski et al, and CLIMB studies)9,10,12
| Characteristic | All patients (n=1,571) |
B/F
|
Placebo
|
||||||
|---|---|---|---|---|---|---|---|---|---|
| Moderate COPD (n=199) |
Severe COPD (n=469) |
Very severe COPD (n=118) |
All patients (n=786) |
Moderate COPD (n=178) |
Severe COPD (n=493) |
Very severe COPD (n=114) |
All patients (n=785) |
||
| Age, years | 63.7 (8.9) | 62.8 (9.4) | 63.9 (8.9) | 63.1 (7.9) | 63.5 (8.9) | 63.5 (9.4) | 64.3 (8.8) | 62.8 (8.1) | 63.9 (8.9) |
| Male, n (%) | 1,204 (76.6) | 127 (63.8) | 370 (78.9) | 106 (89.8) | 603 (76.7) | 122 (68.5) | 384 (77.9) | 95 (83.3) | 601 (76.6) |
| Lung function | |||||||||
| Pre-bronchodilator FEV1, L | 1.13 (0.42) | 1.42 (0.49) | 1.11 (0.34) | 0.72 (0.24) | 1.13 (0.43) | 1.46 (0.41) | 1.10 (0.34) | 0.72 (0.22) | 1.12 (0.41) |
| Reversibility, % predicted | 5.51 (5.83) | 11.30 (7.68) | 4.09 (4.07) | 2.50 (2.98) | 5.67 (6.09) | 10.41 (6.51) | 4.15 (4.39) | 2.52 (2.95) | 5.34 (5.55) |
| Post-bronchodilator FEV1, % predicteda | 42.4 (3.2–79.5) | 54.8 (50.0–76.6) | 41.5 (30.1–50.0) | 25.2 (3.2–30.0) | 42.8 (3.2–76.6) | 54.6 (50.0–79.5) | 40.5 (30.0–49.9) | 25.9 (15.8–30.0) | 42.0 (15.8–79.5) |
| Pre-bronchodilator FEV1/VCb ratio, %a | 45.6 (15.7–108.4) | 53.7 (27.7–86.7) | 43.7 (20.2–87.0) | 31.4 (15.7–93.4) | 45.2 (15.7–93.4) | 54.7 (27.9–108.4) | 45.4 (21.6–85.5) | 34.0 (19.6–65.3) | 45.9 (19.6–108.4) |
| Smoking history, pack-yearsa | 38.0 (10.0–280.0) | 35.0 (10.0–160.0) | 38.0 (10.0–280.0) | 38.5 (10.0–132.0) | 37.0 (10.0–280.0) | 35.0 (10.0–150.0) | 40.0 (10.0–156.0) | 37.0 (10.0–160.0) | 39.0 (10.0–160.0) |
| SGRQ total score | 56.34 (18.92) | 53.57 (19.25) | 55.89 (18.58) | 59.43 (18.39) | 55.79 (18.79) | 56.32 (21.30) | 56.49 (18.30) | 59.56 (18.45) | 56.89 (19.05) |
| Reliever use, inhalations/day | 3.40 (3.12) | 2.86 (2.65) | 3.42 (2.95) | 4.00 (3.15) | 3.37 (2.93) | 2.63 (2.40) | 3.34 (3.16) | 5.07 (4.45) | 3.43 (3.31) |
Notes: Data presented as arithmetic mean (standard deviation) unless otherwise stated.
a
Data are median (range).
b
FVC in one study10 and VC in two studies.9,12 Moderate COPD was defined as post-bronchodilator FEV1 80%–50% predicted, severe COPD as post-bronchodilator FEV1 50%–30% predicted, and very severe COPD as post-bronchodilator FEV1 <30% predicted.
Abbreviations: B/F, budesonide/formoterol; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; SGRQ, St George’s Respiratory Questionnaire; VC, vital capacity.