Table 2 Baseline characteristics by acute exacerbation reported in INPULSIS® trials (mean ± SD or n %)
Patients who did not have an acute exacerbation (n = 998) | Patients who had ≥1 acute exacerbation reported as a serious adverse event (n = 49) | Patients who had ≥1 acute exacerbation but none reported as a serious adverse event (n = 14) | p value for patients who did not have an acute exacerbation vs patients who had ≥1 acute exacerbation reported as a serious adverse event | |
|---|---|---|---|---|
Male | 789 (79.1) | 43 (87.8) | 9 (64.3) | n.s. |
Age, years | 66.6 ± 8.0 | 69.1 ± 7.8 | 69.8 ± 6.7 | n.s. |
Body mass index, kg/m2 | 28.0 ± 4.6 | 27.0 ± 4.1 | 27.2 ± 4.2 | n.s. |
Ex/current smoker | 717 (71.8) | 39 (79.6) | 9 (64.3) | n.s. |
Centrilobular emphysema* | 401 (40.2) | 17 (34.7) | 2 (14.3) | n.s. |
Time since diagnosis, years | 1.6 ± 1.3 | 1.8 ± 1.5 | 1.9 ± 1.3 | n.s. |
FVC, mL | 2746 ± 780 | 2372 ± 628 | 2057 ± 549 | 0.001 |
FVC, % predicted | 80.2 ± 17.8 | 71.5 ± 15.9 | 62.0 ± 7.9 | 0.0008 |
Diffusing capacity of the lung for carbon monoxide†, mmol/min/kPa | 3.9 ± 1.2 | 3.4 ± 1.3 | 3.3 ± 1.0 | 0.0074 |
St. George’s Respiratory Questionnaire total score | 38.9 ± 18.8 | 50.6 ± 17.9 | 45.3 ± 18.2 | < 0.0001 |
Composite physiological index‡ | 45.7 ± 10.8 | 51.3 ± 11.8 | 54.9 ± 8.3 | 0.0004 |
GAP score§ | 3.5 ± 1.3 | 4.2 ± 1.3 | 4.6 ± 1.0 | 0.0002 |
HRCT assessment‖ | ||||
Criteria A, B and C met | 432 (43.3) | 25 (51.0) | 6 (42.9) | n.s. |
Criteria A and C met | 99 (9.9) | 5 (10.2) | 0 (0.0) | n.s. |
Criteria B and C met | 442 (44.3) | 19 (38.8) | 7 (50.0) | n.s. |