Abstract
Introduction: FF and VI are, respectively, a novel inhaled corticosteroid and long-acting beta2 agonist in development as a combined OD therapy for asthma and COPD.
Objectives: To compare the efficacy and safety of FF/VI with FF and fluticasone propionate (FP) in patients (≥12 years old; on ICS) with moderate-to-severe persistent asthma.
Methods: Patients (N=586; intent-to-treat) received FF/VI 200/25mcg OD PM, FF 200mcg OD PM or FP 500mcg twice daily (AM/PM) for 24 weeks. Co-primary endpoints were change from baseline in trough (pre-bronchodilator) FEV1 and weighted mean 0–24h serial FEV1. Secondary endpoints were change from baseline in %rescue-free and %symptom-free 24h periods and Asthma Quality of Life Questionnaire (AQLQ) score. Safety assessments included adverse events (AEs), 24h urinary cortisol (UC) excretion, vital signs and ECG.
Results: FF/VI improved trough FEV1 (diff. 193mL and 210mL; both p<0.001) and weighted mean serial FEV1 (diff. 136mL [p=0.048] and 206mL [p=0.003]) vs FF and FP. Significantly more %rescue-free (11.7 [p<0.001]) and %symptom-free (8.4 [p=0.01]) 24h periods were reported with FF/VI vs FF. There was no statistical difference between FF/VI and FF in AQLQ score. Incidence of AEs was similar across groups. No clinically significant difference was seen across treatments with respect to 24-h UC excretion, vital signs or ECG.
Conclusions: Treatment with FF/VI over 24 weeks was associated with statistically greater improvements in lung function and asthma stability vs FF and FP, and was well tolerated in this asthma population.
Funded by GSK (HZA106829; NCT01134042).
- © 2012 ERS