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Table 3 Summary of adverse events in the treated set

From: Tiotropium Respimat® in asthma: a double-blind, randomised, dose-ranging study in adult patients with moderate asthma

n (%)

Tiotropium Respimat® 5 μga

Tiotropium Respimat® 2.5 μga

Tiotropium Respimat® 1.25 μga

Placebo Respimat®a

 

(n = 146)

(n = 147)

(n = 146)

(n = 144)

Patients with any adverse event

23 (15.8)

20 (13.6)

14 (9.6)

21 (14.6)

Patients with severe adverse events

2 (1.4)

0

0

0

Patients with serious adverse eventsb

2 (1.4)

0

0

0

Patients with investigator-defined drug-related adverse events

3 (2.1)

0

2 (1.4)

2 (1.4)

Patients with adverse events leading to discontinuation of study medication

1 (0.7)

0

0

0

Most frequently reported adverse events (>1 patient on any treatment per treatment period)

Infections and infestations

9 (6.2)

4 (2.7)

6 (4.1)

7 (4.9)

  Nasopharyngitis

5 (3.4)

1 (0.7)

2 (1.4)

2 (1.4)

  Bronchitis

2 (1.4)

0

0

0

  Oral candidiasis

0

0

1 (0.7)

2 (1.4)

  Influenza

1 (0.7)

0

1 (0.7)

0

  Rhinitis

0

0

1 (0.7)

1 (0.7)

Respiratory, thoracic and mediastinal disorders

5 (3.4)

8 (5.4)

4 (2.7)

7 (4.9)

  Asthma exacerbation

4 (2.7)

3 (2.0)

1 (0.7)

5 (3.5)

  Dyspnoea

0

3 (2.0)

0

1 (0.7)

  Cough

0

1 (0.7)

2 (1.4)

0

  1. aAll patients in all groups on a background of maintenance treatment with stable medium-dose inhaled corticosteroids (400–800 μg budesonide or equivalent); bBoth patients experiencing serious adverse events required hospitalisation.