Table S1.
Patient demographics and baseline clinical characteristics, by disease severity and treatment (12-month data set: Calverley et al and Szafranski et al studies only)1,2
| Characteristic | B/F
|
Placebo
|
||||||
|---|---|---|---|---|---|---|---|---|
| Moderate COPD (n=109) |
Severe COPD (n=266) |
Very severe COPD (n=85) |
All patients (n=460) |
Moderate COPD (n=108) |
Severe COPD (n=276) |
Very severe COPD (n=73) |
All patients (n=457) |
|
| Age, years | 62.8 (9.4) | 65.4 (9.0) | 62.8 (8.4) | 64.3 (9.0) | 64.5 (9.1) | 65.5 (8.8) | 63.0 (8.2) | 64.9 (8.8) |
| Male, n (%) | 67 (61.5) | 211 (79.3) | 77 (90.6) | 355 (77.2) | 74 (68.5) | 221 (80.1) | 64 (87.7) | 359 (78.6) |
| Lung function | ||||||||
| Pre-bronchodilator FEV1 L | 1.50 (0.50) | 1.08 (0.36) | 0.74 (0.26) | 1.12 (0.45) | 1.48 (0.45) | 1.08 (0.36) | 0.71 (0.18) | 1.11 (0.43) |
| Reversibility, % predicted | 11.56 (7.89) | 4.52 (4.12) | 2.44 (2.93) | 5.80 (6.08) | 10.69 (6.77) | 4.39 (4.55) | 2.62 (2.96) | 5.60 (5.75) |
| Post-bronchodilator FEV1, % predicteda | 54.8 (50.0–76.6) | 40.4 (30.1–50.0) | 25.4 (3.2–30.0) | 42.1 (3.2–76.6) | 54.5 (50.0–79.5) | 39.8 (30.0–49.9) | 25.2 (15.8–30.0) | 40.8 (15.8–79.5) |
| Pre-bronchodilator FEV1/VC ratio, %a | 55.6 (27.7–86.7) | 43.0 (20.2–87.0) | 30.6 (17.5–93.4) | 43.5 (17.5–93.4) | 55.3 (27.9–108.4) | 43.6 (21.6–85.5) | 32.5 (19.6–65.3) | 45.0 (19.6–108.4) |
| Smoking history, pack-yearsa | 33.0 (10.0–160.0) | 38.5 (10.0–240.0) | 40.0 (10.0–132.0) | 37.5 (10.0–240.0) | 39.5 (10.0–150.0) | 40.0 (10.0–124.0) | 36.0 (12.0–160.0) | 39.0 (10.0–160.0) |
| SGRQ total score | 48.73 (18.90) | 51.04 (18.25) | 56.75 (18.72) | 51.45 (18.62) | 51.58 (21.38) | 52.03 (17.79) | 55.30 (18.08) | 52.44 (18.74) |
| Reliever use, inhalations/day | 2.21 (2.44) | 2.85 (2.95) | 3.51 (3.28) | 2.82 (2.93) | 2.00 (2.03) | 2.46 (2.55) | 4.69 (5.04) | 2.70 (3.10) |
Notes: Data presented as arithmetic mean (standard deviation) unless otherwise stated. Moderate COPD was defined as FEV1 80%–50% predicted, severe COPD as FEV1 50%–30% predicted, and very severe COPD as FEV1 <30% predicted.
a
Data are median (range).
Abbreviations: B/F, budesonide/formoterol; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; SGRQ, St George’s Respiratory Questionnaire; VC, vital capacity.