Pneumonia incidence determined by clinical end-point committee
Study and treatment group | Patients, n | Pneumonia events submitted to clinical end-point committee, n (%) | Pneumonia events confirmed by clinical end-point committee, n (%) |
ETHOS [14] | |||
BUD/GLY/FOR (160/18/9.6 µg) | 2124 | 100 (4.7) | 75 (3.5) |
BUD/GLY/FOR (320/18/9.6 µg) | 2144 | 115 (5.4) | 90 (4.2) |
BUD/FOR (320/9.6 µg) | 2136 | 118 (5.5) | 96 (4.5) |
GLY/FOR (18/9.6 µg) | 2125 | 66 (3.1) | 48 (2.3) |
KRONOS [26] | |||
BUD/GLY/FOR (320/18/9.6 µg; via MDI) | 639 | 16 (2.5) | 12 (1.9) |
BUD/FOR (320/9.6 µg; via MDI) | 314 | 7 (2.2) | 6 (1.9) |
BUD/FOR (400/12 µg; via DPI) | 318 | 6 (1.9) | 4 (1.3) |
GLY/FOR (18/9.6 µg; via MDI) | 625 | 11 (1.8) | 10 (1.6) |
BUD: budesonide; GLY: glycopyrronium; FOR: formoterol; MDI: metered dose inhaler; DPI: dry powder inhaler.