RT Journal Article
SR Electronic
T1 Safety of fluticasone furoate (FF), an inhaled corticosteroid in combination with vilanterol (VI), a long-acting beta agonist in management of COPD exacerbations
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P2113
VO 40
IS Suppl 56
A1 Peter M.A. Calverley
A1 Mark T. Dransfield
A1 Jean Bourbeau
A1 Paul Jones
A1 Nicola A. Hanania
A1 Donald A. Mahler
A1 Jørgen Vestbo
A1 Andrew Wachtel
A1 Fernando Martinez
A1 Frank Barnhart
A1 Lisa Sanford
A1 Sally Lettis
A1 Courtney Crim
YR 2012
UL http://erj.ersjournals.com/content/40/Suppl_56/P2113.abstract
AB Introduction: FF and VI are in development as combined once-daily (OD) therapy for COPDObjectives: Assess the safety of FF/VI (3 strengths) and VI in COPDMethods: In two replicate 1 year studies, after a 28 day run-in with ADVAIR DISKUS® 250/50mcg, subjects received FF/VI 50/25, 100/25, 200/25mcg or VI 25mcg OD. Primary endpoint: annual rate of moderate/severe exacerbations (described separately). Safety endpoints included all, serious and fatal Adverse Events (AEs), Local Steroid Effects (LSE, including candidiasis), bone disorders (BD, including fractures) and pneumoniaResults: Pooled safety findings are shown in the table.View this table:Conclusions: In COPD patients FF/VI exhibited similar rates of serious and fatal AEs to VI, although rates of AE, BD, LSE and pneumonia were greater with FF/VI than VI alone. The efficacy of the combination is reported separatelyFunded by GSK: HZC102871:NCT01009463, HZC102970:NCT01017952.