Table 4.
Maximum post-baseline values and change from baseline in QTc(F), and mean (0–24 h) HR by Holter monitor by visit for patients with ≥16 h of recorded data (intent-to-treat population)
| FF/VI 100/25 µg OD (N=201) |
FF/VI 200/25 µg OD (N=202) |
FP 500 µg BD (N=100) |
|
|---|---|---|---|
| Maximum post-baseline*† QTc(F) (msec) | |||
| n | 199 | 198 | 100 |
| ≤450 | 194 (97) | 195 (98) | 99 (99) |
| >450 to ≤480 | 5 (3) | 3 (2) | 1 (1) |
| >480 to ≤500 | 0 | 0 | 0 |
| >500 | 0 | 0 | 0 |
| Change from baseline QTc(F) (msec) | |||
| n | 199 | 198 | 100 |
| <–60 | 0 | 0 | 0 |
| ≥–60 to <–30 | 0 | 4 (2) | 0 |
| ≥–30 to <0 | 29 (15) | 33 (17) | 18 (18) |
| ≥0 to <30 | 150 (75) | 136 (69) | 74 (74) |
| ≥30 to <60 | 19 (10) | 25 (13) | 8 (8) |
| ≥60 | 1 (<1) | 0 | 0 |
| Mean (0–24 h) HR | |||
| Screening, n | 111 | 116 | 49 |
| Mean (SD) | 79.0 (8.23) | 79.1 (9.55) | 79.8 (8.75) |
| Day 1, n | 104 | 113 | 47 |
| Mean (SD) | 78.6 (7.89) | 78.7 (9.45) | 77.4 (7.66) |
| Week 28, n | 95 | 90 | 39 |
| Mean (SD) | 77.8 (8.90) | 77.5 (9.01) | 74.9 (8.54) |
| Week 52, n | 88 | 82 | 37 |
| Mean (SD) | 78.8 (8.72) | 78.0 (10.15) | 74.8 (8.62) |
*Baseline=Screening.
†Includes assessments at scheduled (Weeks 2, 12, 28 and 52), unscheduled and early withdrawal visits.
BD, twice daily; FF, fluticasone furoate; FP, fluticasone propionate; HR, heart rate; OD, once daily; VI, vilanterol.