RT Journal Article
SR Electronic
T1 Efficacy and safety of fluticasone/formoterol compared to fluticasone alone in patients with asthma
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P2191
VO 40
IS Suppl 56
A1 Tetyana Pertseva
A1 Sanjeeva Dissanayake
A1 Kirsten Kaiser
YR 2012
UL http://erj.ersjournals.com/content/40/Suppl_56/P2191.abstract
AB Background: To demonstrate efficacy and safety of fluticasone propionate/formoterol fumarate pMDI (FLUT/FORM) compared with fluticasone (FLUT) alone based on the change in FEV1 from morning pre-dose at baseline to 2 hours post-dose at week 12.Methods: Patients included in the study were ≥12 years with symptomatic asthma for ≥1 year; steroid-requiring, had FEV1 40% to 80% [inclusive] of predicted normal values, and documented reversibility within 12 months of the study. Following a 2 week open-label run-in phase with FLUT (100 or 200 µg b.i.d.), 438 patients were randomised to treatment with FLUT/FORM (250/10 µg b.i.d.) or one of two pMDI formulations of FLUT alone (250 µg b.i.d.). The formulations were SkyePharma HFA pMDI (SKP) and GSK fluticasone pMDI (FLO), with n=146 in all groups. Albuterol/salmeterol was given as rescue medication.Results: There was a clinically important and statistically significant difference in mean change from pre-dose FEV1 at baseline to 2 h post-dose at week 12 between the FLUT/FORM and both formulations of FLUT (SKP:LS mean difference=0.161 L,P<0.001; FLO:LS mean difference=0.185 L,P<0.001). Results from multiple secondary and tertiary efficacy endpoints assessing lung function, asthma symptoms, exacerbations and rescue medication use supported a superior efficacy of the FLUT/FORM combination over FLUT. Treatment-emergent adverse events were lowest in the FLUT/FORM group (32.9%) compared to SKP (39.7%) or FLO (40.4%). FLUT/FORM was generally well tolerated.Conclusion: FLUT/FORM was superior to FLUT alone in the management of moderate to severe asthma in adolescents and adults. The overall safety profile of FLUT/FORM was consistent with that of FLUT.