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Table 3 Summary of patients affected by respiratory-related adverse events

From: Transient paradoxical bronchospasm associated with inhalation of the LAMA AZD9164: analysis of two Phase I, randomised, double-blind, placebo-controlled studies

AEs classified as Respiratory, Thoracic and/or Mediastinal Disorders

 

Placebo

AZD9164

 

GMAD, healthy subjects

n = 9

400 μg

1000 μg

2800 μg

Total (%)

  

n = 6

n = 6

n = 6

n = 27

Throat irritation

1 (11.1)

0 (0)

1 (16.7)

2 (33.3)

4 (14.8)

Oropharyngeal pain

0 (0)

1 (16.7)

2 (33.3)

0 (0)

3 (11.1)

Cough

0 (0)

0 (0)

0 (0)

1 (16.7)

1 (3.7)

Dyspnoea

0 (0)

0 (0)

1 (16.7)

0 (0)

1 (3.7)

JMAD, healthy subjects

n = 6

400 μg

1000 μg

 

Total (%)

  

n = 6

n = 6

 

n = 18

Cough

0 (0)

1 (16.7)

1 (16.7)

 

2 (11.1)

Epistaxis

0 (0)

0 (0)

1 (16.7)

 

1 (5.6)

Nasal mucosal disorder

0 (0)

0 (0)

1 (16.7)

 

1 (5.6)

Respiratory tract infection

0 (0)

0 (0)

1 (16.7)

 

1 (5.6)

Upper respiratory tract infection

0 (0)

1 (16.7)

0 (0)

 

1 (5.6)

GMAD, COPD patients

n = 1

 

n = 3

 

n = 4

Dyspnoea

1 (100)

 

2 (66.7)

 

2 (50)

Cough

0 (0)

 

1 (33.3)

 

1 (25)