RT Journal Article
SR Electronic
T1 Effect of fluticasone furoate (FF)/vilanterol (VI) once daily (OD) on risk of severe exacerbations in asthma
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P1788
VO 40
IS Suppl 56
A1 Eric D. Bateman
A1 Paul M. O'Byrne
A1 William W. Busse
A1 Jan Lötvall
A1 Eugene R. Bleecker
A1 Leslie Andersen
A1 Brett Haumann
A1 Lucy Frith
A1 Jessica Lim
A1 Loretta Jacques
A1 Ashley Woodcock
YR 2012
UL http://erj.ersjournals.com/content/40/Suppl_56/P1788.abstract
AB Introduction: FF is a novel inhaled corticosteroid in development for the treatment of asthma as a monotherapy and in combination with VI, a long-acting beta2 agonist.Objectives: To evaluate whether FF/VI significantly decreases the risk of severe asthma exacerbations vs FF.Methods: Patients (N=2019; ITT) received OD FF/VI 100/25mcg or FF 100mcg for ≥24 weeks (up to 76 weeks; study planned to finish after 330 events; event defined as a patient's first on-treatment severe asthma exacerbation). Primary endpoint was time to first severe asthma exacerbation. Secondary endpoints: rate of severe asthma exacerbations per patient per year (PPPY) and change from baseline trough FEV1. Safety assessments included adverse events (AE), vital signs and number of hospitalisations due to a severe asthma exacerbation.Results: Compared with FF, FF/VI delayed the time to first severe exacerbation (hazard ratio 0.795 [95% CI: 0.642,0.985]; interim adj p=0.036). The adjusted probability of experiencing a severe exacerbation by 52 weeks was 12.8% for FF/VI and 15.9% for FF. PPPY rate was reduced (FF/VI 0.14 vs FF 0.19; p=0.014). There were greater improvements in trough FEV1 with FF/VI vs FF at Weeks 12, 36 and 52 (p<0.001). Incidence of treatment-related AEs: FF/VI 7%, FF 7% (on-treatment serious AEs: FF/VI 4%, FF 3%). Number of hospitalisations due to severe exacerbation was similar between treatments. There were no clinically relevant differences in vital sign assessments.Conclusions: FF/VI significantly reduced the risk of severe asthma exacerbations and improved lung function compared with FF alone. Safety and tolerability were similar between groups.Funded by GSK: HZA106837; NCT01086384.