Table 2.
Treatment-emergent AEs in healthy volunteers and COPD patients
| 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) |
A patient with multiple AEs is counted only once
a2 subjects at 1200 μg and 1 at 2400 μg
b1 subject had received placebo + charcoal
cat 1200 μg
dat 2000 μg
eat 800 μg