Abstract
Introduction: FF and VI are in development as combined once-daily (OD) therapy for COPD
Objectives: Assess the safety of FF/VI (3 strengths) and VI in COPD
Methods: 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 pneumonia
Results: Pooled safety findings are shown in the 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 separately
Funded by GSK: HZC102871:NCT01009463, HZC102970:NCT01017952.
- © 2012 ERS