Table 4

Subjects with Respiratory Adverse Events (All events reported at ≥3.0% in any year)

Year 1 a

Year 2

Year 3

Year 4 b

Year 5 b


Adverse Event

BT

(n = 45)

Control

(n = 24)

BT

(n = 45)

Control

(n = 24)

BT

(n = 43)

Control

(n = 21)

BT

(n = 43)

BT

(n = 42)


Dyspnea

19 (42.2%)

12 (50.0%)

4 (8.9%)

3 (12.5%)

4 (9.3%)

3 (14.3%)

4 (9.3%)

4 (9.5%)

Cough

17 (37.8%)

7 (29.2%)

4 (8.9%)

1 (4.2%)

2 (4.7%)

3 (14.3%)

3 (7.0%)

2 (4.8%)

Wheeze

14 (31.1%)

4 (16.7%)

2 (4.4%)

1 (4.2%)

3 (7.0%)

1 (4.8%)

3 (7.0%)

2 (4.8%)

Nasal congestion

13 (28.9%)

5 (20.8%)

2 (4.4%)

0

0

0

0

1 (2.4%)

Upper Respiratory Tract Infection

10 (22.2%)

2 (8.3%)

11 (24.4%)

4 (16.7%)

8 (18.6%)

4 (19.1%)

8 (18.6%)

4 (9.5%)

Productive cough

9 (20.0%)

5 (20.8%)

2 (4.4%)

1 (4.2%)

2 (4.7%)

0

0

1 (2.4%)

Chest discomfort

8 (17.8%)

3 (12.5%)

2 (4.4%)

2 (8.3%)

3 (7.0%)

1 (4.8%)

1 (2.3%)

2 (4.8%)

Nasopharyngitis

6 (13.3%)

0

1 (2.2%)

0

0

0

1 (2.3%)

1 (2.4%)

Nocturnal Dyspnea

6 (13.3%)

2 (8.3%)

0

0

0

0

0

0

Respiratory Tract Infection c

5 (11.1%)

5 (20.8%)

3 (6.7%)

2 (8.3%)

5 (11.6%)

1 (4.8%)

5 (11.6%)

4 (9.5%)

Pharyngolaryngeal pain

5 (11.1%)

3 (12.5%)

0

0

0

0

0

0

Respiratory Tract congestion

4 (8.9%)

2 (8.3%)

0

0

0

0

0

0

Discolored sputum

4 (8.9%)

0

3 (6.7%)

0

0

0

0

0

Rhinitis

2 (4.4%)

0

0

0

1 (2.3%)

0

0

2 (4.8%)

Bronchitis d

1 (2.2%)

0

1 (2.2%)

1 (4.2%)

1 (2.3%)

2 (9.5%)

1 (2.3%)

1 (2.4%)

Pharyngitis

1 (2.2%)

1 (4.2%)

0

0

0

0

0

0

Pleuritic Pain

1 (2.2%)

1 (4.2%)

0

0

0

0

0

0

Rhinorrhea

1 (2.2%)

1 (4.2%)

0

0

1 (2.3%)

0

0

0

Asthma (multiple symptoms) e

0

0

4 (8.9%)

2 (8.3%)

7 (16.3%)

1 (4.8%)

7 (16.3%)

6 (14.3%)

Sinusitis

0

0

1 (2.2%)

1 (4.2%)

2 (4.7%)

0

2 (4.7%)

2 (4.8%)

Nasal polyps

0

0

1 (2.2%)

0

0

0

2 (4.7%)

0

Pneumonia

0

0

0

0

1 (2.3%)

1 (4.8%)

0

0


a: Year 1 data only for subjects who enrolled for longer-term follow-up. Adverse events solicited from patient during multiple office visits in Year 1. In subsequent years, adverse events solicited only at annual follow-up visit.

b: Control group subjects exited from Study after Year 3 evaluations.

c: Includes adverse events reported as "Respiratory Tract Infection" and "Lower Respiratory Tract Infection".

d: Includes adverse events reported as "Bronchitis" and "Tracheobronchitis".

e: Asthma - In Year 1, all symptoms were collected as individual adverse events; in subsequent years, multiple symptoms of asthma exacerbation were considered as a single adverse event.

Thomson et al. BMC Pulmonary Medicine 2011 11:8   doi:10.1186/1471-2466-11-8

Open Data