Table 2.
Summary of SGRQ endpoints (ITT population)
| UMEC/VI 62.5/25 μg (n=248) |
PBO (n=248) |
|
|---|---|---|
| SGRQ score on day 28 | ||
| LS mean change from baseline (SE)a | −5.41 (0.711) | −0.14 (0.717) |
| Difference vs PBO (95% CI) | −5.27 (−7.26, −3.28)* | |
| Proportion of respondersb,c according to SGRQ total score on day 28 | ||
| Responder, n (%) | 113 (48) | 67 (29) |
| OR vs PBO, (95% CI) | 2.35 (1.58, 3.49)* | |
| SGRQ score on day 56 | ||
| LS mean change from baseline (SE)d,e | −6.04 (0.775) | −2.30 (0.778) |
| Difference vs PBO (95% CI) | −3.73 (−5.89, −1.57)* | |
| Proportion of respondersb,f according to SGRQ total score on day 56 | ||
| Responder, n (%) | 119 (51) | 94 (40) |
| OR vs PBO, (95% CI) | 1.53 (1.05, 2.23)** | |
| SGRQ score on day 84 | ||
| LS mean change from baseline (SE)g | −6.15 (0.803) | −2.12 (0.808) |
| Difference vs PBO (95% CI) | −4.03 (−6.28, −1.79)* | |
| Proportion of respondersb,h according to SGRQ total score on day 84 | ||
| Responder, n (%) | 123 (51) | 94 (40) |
| OR vs PBO, (95% CI) | 1.61 (1.11, 2.34)*** | |
Notes:
P<0.001;
P=0.026;
P=0.013.
Number of patients with analyzable data at this time point: UMEC/VI 62.5/25 μg, n=225; PBO, n=221.
Response is defined as an SGRQ total score of 4 units below baseline (scores recorded prior to dosing on day 1 or lower).
UMEC/VI 62.5/25 μg, n=236; PBO, n=232.
Number of patients with analyzable data at this time point: UMEC/VI 62.5/25, n=220; PBO, n=220.
LS mean change from baseline: UMEC/VI 62.5/25 μg, −6.0381; PBO, −2.3047.
UMEC/VI 62.5/25 μg, n=235; PBO, n=235.
Number of patients with analyzable data at this time point: UMEC/VI 62.5/25 μg, n=212; PBO, n=210.
UMEC/VI 62.5/25 μg, n=239; PBO, n=236.
Abbreviations: CI, confidence interval; ITT, intent-to-treat; LS, least squares; OR, odds ratio; PBO, placebo; SE, standard error; SGRQ, St George’s Respiratory Questionnaire; UMEC, umeclidinium; VI, vilanterol.