From: Efficacy and safety of AZD3199 vs formoterol in COPD: a randomized, double-blind study
AZD3199 | AZD3199 | AZD3199 | Formoterol | Placebo | |
---|---|---|---|---|---|
200 μg od (n = 65) | 400 μg od (n = 69) | 800 μg od (n = 65) | 9 μg bid (n = 67) | (n = 63) | |
Gender (%) | |||||
Male | 47 (72.3) | 53 (76.8) | 45 (69.2) | 51 (76.1) | 51 (81.0) |
Female | 18 (27.7) | 16 (23.2) | 20 (30.8) | 16 (23.9) | 12 (19.0) |
Age (years) | 62.4 (45–81) | 63.8 (40–82) | 65.3 (41–92) | 64.1 (47–77) | 64.8 (46–84) |
Race (%) | |||||
White | 49 (75.4) | 53 (76.8) | 48 (73.8) | 51 (76.1) | 48 (76.2) |
Asian | 16 (24.6) | 16 (23.2) | 17 (26.2) | 16 (23.9) | 15 (23.8) |
BMI (kg/m 2 ) | 26.6 (18–41) | 25.3 (18–35) | 25.3 (18–47) | 25.4 (18–36) | 25.7 (19–38) |
Time since COPD diagnosis (years) a | 4.1 (0–19) | 3.1 (0–29) | 3 (0–18) | 4.1 (0–24) | 3.5 (0–17) |
Smoking status (%) | |||||
Ex-smoker | 34 (52.3) | 32 (46.4) | 27 (41.5) | 36 (53.7) | 27 (42.9) |
Current | 31 (47.7) | 37 (53.6) | 38 (58.5) | 31 (46.3) | 36 (57.1) |
Pack-years (years) | 36 (10–145) | 41 (10–156) | 46 (10–126) | 39 (10–123) | 40 (10–140) |
Total COPD symptom score | 6.0 (2–12) | 5.8 (2–12) | 6.0 (1–12) | 5.8 (1–14) | 5.7 (0–11) |
FEV 1 (% predicted normal) b | 60.1 (41.4–79.8) | 63.1 (39.7–79.6) | 60.6 (40.4–79.9) | 60.9 (40.4–79.9) | 61.3 (41.7–78.5) |
Reversibility (%) | 7.4 (−11.0–27.9) | 11.9 (−12.4–74.4) | 10.1 (−14.1–29.6) | 9.4 (−17.1–44.8) | 6.8 (−7.7–51.0) |
FEV 1 /FVC (%) b | 55.2 (30.9–69.9) | 56.1 (28.5–70.0) | 52.4 (28.6–69.9) | 54.6 (31.9–72.3) | 56.1 (33.1–69.0) |
ICS use (%) c | 33 (50.8) | 42 (60.9) | 37 (56.9) | 44 (65.7) | 37 (58.7) |
ICS dose c (μg) | 737.6 (320–1000) | 638.1 (200–1000) | 620.5 (320–2000) | 649.3 (200–1500) | 671.1 (250–1000) |
LAMA use (%) d | 10 (15.4) | 11 (15.9) | 19 (29.2) | 11 (16.4) | 16 (25.4) |
LABA use (%) e | 29 (44.6) | 30 (43.5) | 29 (44.6) | 28 (41.8) | 28 (44.4) |
SAMA use (%) f | 14 (21.5) | 16 (23.2) | 9 (13.8) | 9 (13.4) | 14 (22.2) |
SABA use (%) g | 41 (63.1) | 44 (63.8) | 40 (61.5) | 41 (61.2) | 41 (65.1) |
Other COPD medication h | 13 (20.0) | 10 (14.5) | 10 (15.4) | 15 (22.4) | 10 (15.9) |