Table 4.
Effect of 52 weeks’ treatment on SGRQ total score according to baseline severity and therapy group
| Severity subgroup | Placebo | Sal/FP | Sal | FP |
|---|---|---|---|---|
| FEV1<50% predicted | ||||
| Patients (n) | 211 | 205 | 212 | 219 |
| Mean baseline SGRQ | 49.8 | 50.2 | 51.3 | 51.1 |
| Adjusted mean change in SGRQ | −1.3 | −3.6 | −2.6 | −1.7 |
| Treatment difference vs placebo (95% CI)a | - | −2.3 (−3.7, −0.8) | −1.3 (−2.8, 0.1) | −0.5 (−1.9, 1.0) |
| Treatment difference vs Sal/FP (95% CI)b | - | - | −0.9 (−2.4, 0.5) | −1.8 (−3.2, −0.4) |
| p-value vs placebo | - | 0.002 | 0.069 | 0.527 |
| p-value vs Sal/FP | - | - | 0.201 | 0.014 |
| FEV1≥50% predicted | ||||
| Patients (n) | 107 | 115 | 108 | 121 |
| Mean baseline SGRQ | 41.0 | 41.3 | 43.0 | 47.4 |
| Adjusted mean change in SGRQ | −2.1 | −4.0 | −2.7 | −3.5 |
| Treatment difference vs placebo (95% CI)a | - | −1.9 (−3.9, 0.1) | −0.6 (−2.6, 1.4) | −1.4 (−3.3, 0.6) |
| Treatment difference vs Sal/FP (95% CI)b | - | - | −1.3 (−3.3, 0.7) | −0.6 (−2.5, 1.4) |
| p-value vs placebo | - | 0.058 | 0.544 | 0.175 |
| p-value vs Sal/FP | - | - | 0.199 | 0.572 |
a
Treatment difference – a negative value indicates superiority of active group (improvement in SGRQ).
b
Treatment difference – a negative value indicates superiority of Sal/FP over individual components.
(A clinically relevant reduction in SGRQ total score is a decline of at least 4 points.)
Abbreviations: FP, fluticasone propionate; Sal/FP, salmeterol and fluticasone propionate combination; Sal, salmeterol; SGRQ, St George’s Respiratory Questionnaire.