COPD patients | Healthy volunteers | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Placebo (n = 20) | V0162 (n = 20) | Tiotropium (n = 20) | Placebo (n = 22) | V0162 (n = 66) | ||||||
Adverse event | Event n | Patients n (%) | Event n | Patients n (%) | Event n | Patients n (%) | Event n | Patients n (%) | Event n | Patients n (%) |
Total | 28 | 8 (40) | 42 | 16 (80) | 23 | 12 (60) | 6 | 4 (18) | 7 | 5 (8) |
Cough | 7 | 4 (20) | 14 | 10 (50) | 7 | 6 (30) | 1 | 1 (4.5) | 3 | 3a (4.5) |
Dyspnea | 5 | 4 (20) | 8 | 7 (35) | 6 | 4 (20) | - | - | - | - |
Productive Cough | 7 | 4 (20) | 6 | 6 (30) | 4 | 4 (20) | - | - | - | - |
Headache | 3 | 3 (15) | 3 | 3 (15) | 3 | 3 (15) | 3b | 3 (13.6) | - | - |
Throat Irritation | 1 | 1 (5) | 3 | 3 (15) | 1 | 1 (5) | 1 | 1 (4.5) | - | - |
Wheezing | 1 | 1 (5) | 2 | 1 (5) | 1 | 1 (5) | - | - | - | - |
Pruritus | - | - | 3 | 3 (15) | - | - | - | - | 1 | 1c (1.5) |
Abdominal pain | 1 | 1 (5) | - | - | - | - | - | - | 1 | 1c (1.5) |
Angina Pectoris | - | - | - | - | 1 | 1 (5) | - | - | - | - |
Dizziness | 1 | 1 (5) | - | - | - | - | - | - | - | - |
Erysipelas | 1 | 1 (5) | - | - | - | - | - | - | - | - |
Erythema | 1 | 1 (5) | - | - | - | - | - | - | - | - |
Fatigue | - | - | 1 | 1 (5) | - | - | - | - | - | - |
Diarrhea | - | - | 1 | 1 (5) | - | - | - | - | - | - |
Dry Mouth | - | - | 1 | 1 (5) | - | - | - | - | - | - |
Nausea | - | - | - | - | - | - | 1 | 1 (4.5) | 1 | 1d (1.5) |
Epistaxis | - | - | - | - | - | - | - | - | 1 | 1e (1.5) |