Abstract
Introduction: FF OD is effective in asthma patients (pts) uncontrolled by low-dose ICS (100mcg, 200mcg) or mid-dose ICS (200mcg).
Objective: To assess efficacy/safety of two strengths of FF in pts (aged ≥12 years) with moderate-to-severe persistent asthma uncontrolled on a total daily dose of FP >250–1000mcg (or equivalent).
Methods: Randomised, double-blind, parallel-group, descriptive (no formal inference was planned) study (N=219; ITT) of FF 100mcg or FF 200mcg OD in the PM via dry powder inhaler for 24 weeks. Endpoints (all Δ baseline [BL]): primary – trough (pre-bronch.) FEV1; secondary/other – %rescue-free 24-h periods (%RF), PM/AM PEF, %symptom-free 24-h periods (%SF), Asthma Control Test (ACT) scores. Safety: AEs, 24-h urine cortisol (UC) excretion, laboratory tests.
Results: Data are for FF 100, FF 200. FF increased trough FEV1 (208mL, 284mL), %RF (21.3, 23.1), PM PEF (5.9L/min, 7.2L/min), AM PEF (13.4L/min, 13.2L/min), %SF (17.5, 19.6), ACT score (4.5, 4.9) and %pts ACT score ≥20 (53%, 59%). See Figure for treatment differences. AE profile was broadly similar across groups, except treatment-related AEs (<1%, 5%). No clinically relevant Δ 24-h UC (ratio vs BL: 1.15, 1.09) or laboratory tests.
Conclusions: Relative to baseline, FF showed consistent improvements in efficacy (often numerically greater with FF 200mcg) and no safety concerns.
Funded by GSK (FFA114496;NCT01431950).
- © 2013 ERS
