PT  - JOURNAL ARTICLE
AU  - William W. Busse
AU  - Paul M. O'Byrne
AU  - Eugene R. Bleecker
AU  - Jan Lötvall
AU  - Ashley Woodcock
AU  - Leslie Andersen
AU  - Jody West
AU  - Loretta Jacques
AU  - Ludovic Apoux
AU  - Eric D. Bateman
TI  - Safety and tolerability of the novel inhaled corticosteroid (ICS) fluticasone furoate (FF) in combination with the long-acting beta<sub>2</sub> agonist (LABA) vilanterol (VI) administered once daily (OD) in patients with asthma
DP  - 2012 Sep 01
TA  - European Respiratory Journal
PG  - P2092
VI  - 40
IP  - Suppl 56
4099  - http://erj.ersjournals.com/content/40/Suppl_56/P2092.short
4100  - http://erj.ersjournals.com/content/40/Suppl_56/P2092.full
SO  - Eur Respir J2012 Sep 01; 40
AB  - Introduction: The ICS FF in combination with the LABA VI is in development for asthma and COPD.Objectives: To assess the safety and tolerability of FF/VI over 52 weeks in patients with asthma.Methods: Patients (N=503) were randomised (2:2:1) to FF/VI 100/25mcg or FF/VI 200/25mcg OD in the evening, or fluticasone propionate (FP) 500mcg twice daily. Safety evaluations included adverse events (AEs), non-fasting glucose and potassium, urinary cortisol (UC), heart rate (HR), pulse rate and ophthalmic assessments.Results: Statistically significant UC suppression was seen with FP compared with both FF/VI groups at Weeks 12 and 28 (p≤0.006), but not at Week 52. Potassium and glucose values were similar across groups. Increases in pulse rate (10min post dose; Week 52) were reported with FF/VI vs FP (FF/VI 100/25mcg: 3.4bpm, p=0.002; FF/VI 200/25mcg: 3.4bpm, p=0.003). No significant effects with FF/VI vs FP were observed on QTc(F) outputs or HR with Holter monitoring. AEs were reported by 66–69% of patients on FF/VI and by 73% on FP. Oral/oropharnygeal candidiasis AEs: FF/VI (6–7%), FP (3%). Twelve SAEs were reported; one (worsening hepatitis on FP) was considered drug related. Low number of 'special interest' AEs (including ocular effects and pneumonia).Conclusion: FF/VI (100/25mcg or 200/25mcg) administered once daily over 52 weeks was well tolerated by patients aged ≥12 years with asthma. The overall safety profile observed for FF/VI did not reveal any findings of significant clinical concern and was similar to FP.Funded by GSK (HZA106839; NCT01018186).