Characteristic | Formoterol 4.5 µg | Formoterol 9 µg | Formoterol 18 µg | Placebo | All |
Patients in efficacy analysis n (M:F) | 171 (112:59) | 166 (119:47) | 177 (123:54) | 173 (113:60) | 687 (467:220) |
Patients who completed study n | 144 | 136 | 150 | 146 | 576 |
Age yrs | 62.7 (49–78) | 63.3 (50–79) | 61.9 (50–78) | 61.8 (50–77) | 62.4 (49–79) |
Time since diagnosis yr | 7.5 (0–31) | 7.0 (0–43) | 6.1 (0–39) | 6.1 (0–31) | 6.6 (0–43) |
Smokers: habitual/occasional/previous | 70/9/92 | 68/7/91 | 77/7/93 | 79/9/85 | 294/32/361 |
FEV1 L# | 1.44 (0.72–2.51) | 1.49 (0.73–2.88) | 1.51 (0.90–2.48) | 1.47 (0.71–0.57) | 1.48 (0.71–2.88) |
FEV1 % pred | 53.1 (38–70) | 54.4 (30–73) | 54.7 (37–71) | 53.8 (38–70) | 54.0 (30–73) |
FVC L# | 2.59 (1.05–4.36) | 2.68 (0.98–6.08) | 2.64 (1.41–5.53) | 2.60 (1.11–5.53) | 2.63 (0.98–6.08) |
FEV1/FVC % pred | 74.1 (41–127) | 74.5 (41–112) | 76.0 (40–119) | 75.2 (42–116) | 75.0 (40–127) |
Reversibility % pred | 6.7 (−35–55) | 5.8 (−14–44) | 6.5 (−12–92) | 6.7 (−27–41) | 6.4 (−35–92) |
BDI | 6.2 (0–12) | 6.4 (0–11) | 6.4 (0–12) | 6.5 (0–12) | 6.4 (0–12) |
Puffs of relief medication·night−1 | 0.54 (0–3.2) | 0.52 (0–4.4) | 0.63 (0–6.8) | 0.51 (0–8.4) | 0.55 (0–8.4) |
Puffs of relief medication·day−1 | 2.95 (0–11.3) | 2.77 (0–12.4) | 3.05 (0–11.1) | 2.70 (0–8.7) | 2.87 (0–12.4) |
Total symptom score# | 5.94 (1.9–13.6) | 5.30 (1.2–12.3) | 5.71 (1.4–13.2) | 5.55 (1.0–14.2) | 5.63 (1.0–14.2) |
Sleep disturbance | 1.84 (1.0–4.3) | 1.64 (1.0–3.7) | 1.77 (1.0–4.0) | 1.73 (1.0–4.8) | 1.74 (1.0–4.8) |
Breathlessness | 2.61 (1.0–5.0) | 2.48 (1.0–4.6) | 2.63 (1.0–4.9) | 2.51 (1.0–4.6) | 2.56 (1.0–5.0) |
Cough | 2.32 (1.0–5.0) | 2.16 (1.0–5.0) | 2.29 (1.0–4.8) | 2.31 (1.0–5.0) | 2.27 (1.0–5.0) |
Chest tightness | 1.94 (1.0–5.0) | 1.91 (1.0–4.2) | 1.91 (1.0–4.7) | 1.88 (1.0–4.9) | 1.91 (1.0–5.0) |
Data are presented as mean (range)
M: male
F: female
FEV1: forced expiratory volume in one second
FVC: forced vital capacity
BDI: baseline dyspnoea index
#: geometric mean