Table 3.
Summary and analysis of first deterioration events in the ITT and MN populations
| Components of the first CID | UMEC/VI 62.5/25 | TIO | Hazard ratio, UMEC/VI vs. TIO (95% CI) |
|---|---|---|---|
| ITT population, n | 878 | 869 | |
| ≥100 ml decrease in trough FEV1 | 159 (18) | 308 (35) | 0.44 (0.36 to 0.53)* |
| ≥4-unit SGRQ total score increase | 208 (24) | 236 (27) | 0.83 (0.69 to 1.00)† |
| Moderate-to-severe COPD exacerbation | 56 (6) | 54 (6) | 1.02 (0.70 to 1.48) |
| MN population, n | 275 | 258 | |
| ≥100 ml decrease in trough FEV1 | 53 (19) | 93 (36) | 0.44 (0.32 to 0.62)* |
| ≥4-unit SGRQ total score increase | 66 (24) | 69 (27) | 0.92 (0.65 to 1.29) |
| Moderate-to-severe COPD exacerbation | 13 (5) | 9 (3) | 1.33 (0.57 to 3.13) |
Data presented as n (%) unless otherwise indicated
CI confidence interval, CID clinically important deterioration, COPD chronic obstructive pulmonary disease, FEV 1 forced expiratory volume in 1 s, ITT intent to treat, MN maintenance-naïve, SGRQ St George’s respiratory questionnaire, TIO tiotropium, UMEC umeclidinium, VI vilanterol
* P < 0.001, † P < 0.05