Table 2.
Major clinical trials using inhaled fluticasone furoate in asthma.
| Type of study | Number of patients | Design | Outcomes | Conclusions | Reference |
|---|---|---|---|---|---|
| 1. R, DB, MC, PC | 598 | FF (20, 50, 100 or 200 μg) daily versus P daily × 8 weeks | FF 50–200 μg improved FEV1, from baseline | FF 50–200 μg demonstrated dose–response improvement with 100–200 μg being the optimal doses | [Bateman et al. 2012] |
| 2. R, DB, MC, PC | 646 | FF (200 or 400 μg) once each morning, FF (200 or 400 μg) once each evening or FF (200 μg) twice daily versus P × 8 weeks | All doses of FF significantly improved trough FEV1 compared with P; FF 400 μg once each evening and FF 200 μg twice daily had similar efficacy | Excellent tolerability without significant AEs. Both FF (200 or 400 μg) were more effective than P in improving trough FEV1; FF 200 μg twice daily = FF 400 μg | [Woodcock
et al. 2011a] |
| 3. R, DB, X, MC, PC | 190 | FF (100 μg) twice daily, FF (200 μg)daily, FP (100 μg) twice daily, FP (200 μg) daily or P, × 3~28 day periods with crossover design | FF (200 μg) daily was noninferior to FF (100 μg) twice daily in improving trough FEV1. All FF and FP doses were superior to P in improving trough FEV1 | No significant AEs; FF (200 μg) daily was more effective than P and not inferior to the same twice daily dose | [Woodcock et al. 2011b] |
| 4. R, DB, MC, PC | 627 | FF (200, 400 600 or 800 μg) once each evening or FP (500 μg) twice daily versus P once each evening, × 8 weeks | All doses of once-daily FF and twice-daily FP were significantly superior to P in improving trough FEV1. Oral candidiasis was higher with FF (800 μg) than P | FF doses < 800 μg have a favorable therapeutic index. Doses of FF of 200 μg daily appear appropriate | [Busse et al. 2012] |
| 5. R, DB, DD, PG, MC, PC | 575 | FF (100 μg) once each morning or FF (100–250 μg) once each evening or P once each morning or once each evening, × 4 weeks | All doses and times of FF statistically improved the PEF compared with P. No study drug AEs seen | FF 100 μg once each morning or once each evening appeared to give comparable improvement in PEF compared with P given once each morning or once each evening | [Medley et al. 2012] |
| 6. R, DB, DD, MC, PC | 343 | FF (100 μg) once each evening, FP (250 μg) twice daily or P twice daily | Both once daily FF and twice daily FP significantly improved predose FEV1 at 24 weeks compared with P. On treatment asthma exacerbations were FF (3%), FP (2%) and both were lower than P (7%) | FF (100 μg) once each evening resulted in improved FEV1 comparable to that seen with FP (250 μg) twice daily with a similar safety profile | [Lotvall
et al. 2014b] |
| 7. R, DB, MC, PG | 239 | FF (100 μg) once each evening, FF (200 μg) once each evening, × 24 weeks | Both FF doses resulted in significant increases in trough FEV1 from baseline | Both doses of FF resulted in improved trough FEV1 compared with baseline | [Woodcock et al. 2014] |
| 8. R, DB, DD, PG, MC, PC | 351 | FF (50 μg) once each evening, FP (100 μg) BID or P BID, × 24 weeks | No significant improvement in trough FEV1 with FF (50 μg) once each evening was seen but the improvement was significant with FP (100 μg) twice daily | FP (100 μg) twice daily but not FF (50 μg) once each evening improved through FEV1 | [Busse et al. 2014] |
| 9. R, DB, PG, MC, PC | 248 | FF (50 μg) once each evening or P once each evening, × 12 weeks | A significant increase in trough FEV1 was seen after FF (50 μg) once each evening compared with P once each evening. Significant reduction in rescue inhaler use was seen with FF compared with P. AEs <1% (FF) and 3% (P) | FP (50 μg) once each evening improved trough FEV1 and reduced rescue inhaler use compared with P | [O’Byrne et al. 2014b] |
AE, adverse event; DB, double blind; DD, double dummy; FEV1, forced expiratory volume 1 s; FF, fluticasone furoate; FP, fluticasone propionate; MC, multicenter; P, placebo; PC, placebo controlled; PEF, peak expiratory flow; PG, parallel group; R, randomized; X, crossover.