Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial

BMC Pulmonary Medicine

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.

ISSN: 1471-2466