Table 1.
Clinical trials of the effect of fluticasone propionate/salmeterol combination therapy on lung function, symptoms and health status
| Study | No. of patients (duration) | Treatment comparisons | Major findings: lung function | Major findings: health status and symptoms |
|---|---|---|---|---|
| Calverley et al 200350 | 1465 (52 weeks) | Twice daily FSC 500/50 μg vs FP 500 μg, SAL 50 μg, or placebo | FEV 1 increased with FSC compared to FP, SAL and placebo | Health status score (SGRQ) was improved with FSC at week 8 (−4.3, SD 10.8) and 52 (−4.5, SD 12.9) compared to placebo and FP Dyspnea and use of relief medication improved with FSC compared to placebo, FP and SAL. Night-time awakenings decreased with FSC compared to placebo and SAL |
| Mahler et al 200252 | 691 (24 weeks) | Twice daily FSC 500/50 μg vs FP 500 μg, SAL 50 μg, or placebo | Pre-dose FEV1 increased with FSC compared to SAL and placebo; 2-hour post-dose FEV1 increased with FSC compared to FP and placebo; dyspnea score improved with FSC compared to FP and placebo | Health status improved with FSC (CDRQ, 10.0) compared to placebo (5.0) and FP (4.8), but not compared to SAL (8.0) Dyspnea and use of relief medication improved with FSC compared to SAL, FP and placebo. Night-time awakenings decreased with FSC compared to SAL and placebo |
| Hanania et al 200336 | 723 (24 weeks) | Twice daily FSC 250/50 μg vs FP 250 μg, SAL 50 μg, or placebo | Morning pre-dose FEV1 increased with FSC compared to SAL and placebo; 2-hour post-dose FEV1increased with FSC compared to FP and placebo | Health status improved with FSC compared to placebo (CDRQ, +5.2) but not compared to FP or SAL Dyspnea improved with FSC and SAL compared to placebo. Use of rescue medication decreased with FSC compared to placebo and FP. Night-time awakenings decreased with FSC compared to placebo and SAL |
| Celli et al 200856 | 5343 (3 years) | Twice daily FSC 500/50 μg vs FP 500 μg, SAL 50 μg, or placebo | The rate of decline in FEV1 was reduced with FSC, FP and SAL compared to placebo; greatest reduction was with FSC compared to placebo; differences between treatment arms were not significant | Not assessed |
Abbreviations: CRDQ, chronic respiratory disease questionnaire; FP, fluticasone propionate; FSC, fluticasone propionate/salmeterol combination; SAL, salmeterol; SGTQ, St George’s respiratory questionnaire; TDI, transition dyspnea index.