Table 3.
Summary and analysis of first and sustained CID in Study B (ITT population)
| Deterioration criteria | UMEC/VI (n=454) | TIO (n=451) |
|---|---|---|
| First deterioration | ||
| Composite (any event), n (%) | 188 (41) | 266 (59) |
| UMEC/VI vs TIO, HR (95% CI) | – | 0.57 (0.47, 0.69)*** |
| ≥100 mL decrease in trough FEV1, n (%) | 95 (21) | 170 (38) |
| UMEC/VI vs TIO, HR (95% CI) | – | 0.47 (0.36, 0.60)*** |
| ≥4-unit SGRQ total score increase, n (%) | 105 (23) | 131 (29) |
| UMEC/VI vs TIO, HR (95% CI) | – | 0.74 (0.58, 0.96)* |
| Moderate-to-severe COPD exacerbationa, n (%) | 16 (4) | 29 (6) |
| UMEC/VI vs TIO, HR (95% CI) | – | 0.53 (0.29, 0.98)* |
| Sustained deterioration | ||
| Composite (any event), n (%)b | 90 (20) | 150 (33) |
| UMEC/VI vs TIO, HR (95% CI) | – | 0.53 (0.40, 0.68)*** |
| ≥100 mL decrease in trough FEV1, n (%) | 42 (9) | 83 (18) |
| UMEC/VI vs TIO, HR (95% CI) | – | 0.44 (0.31, 0.64)*** |
| ≥4-unit SGRQ total score increase, n (%) | 34 (7) | 51 (11) |
| UMEC/VI vs TIO, HR (95% CI) | – | 0.64 (0.41, 0.99)* |
Notes:
*
P<0.05.
***
P<0.001.
a
Defined as an acute worsening of COPD symptoms requiring the use of additional treatment including oral corticosteroids, antibiotics, emergency department treatment, or hospitalization.
b
Any first exacerbation was also considered a sustained deterioration as patients were withdrawn by protocol following a first event.
Abbreviations: CI, confidence interval; CID, clinically important deterioration; FEV1, forced expiratory volume in 1 second; HR, hazard ratio; ITT, intent-to-treat; SGRQ, St George’s Respiratory Questionnaire; TIO, tiotropium; UMEC, umeclidinium; VI, vilanterol.