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Table 2 Treatment-emergent AEs in healthy volunteers and COPD patients

From: V0162 a new long-acting bronchodilator for treatment of chronic obstructive lung diseases: preclinical and clinical results

 

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)

  1. A patient with multiple AEs is counted only once
  2. a2 subjects at 1200 μg and 1 at 2400 μg
  3. b1 subject had received placebo + charcoal
  4. cat 1200 μg
  5. dat 2000 μg
  6. eat 800 μg
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Respiratory Research

ISSN: 1465-993X

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