TY - JOUR
T1 - Efficacy of fluticasone propionate/formoterol fumarate in the treatment of asthma
T2 - A pooled analysis
AU - Papi, Alberto
AU - Price, David
AU - Sastre, Joaquin
AU - Kaiser, Kirsten
AU - Lomax, Mark
AU - McIver, Tammy
AU - Dissanayake, Sanjeeva
N1 - Copyright © 2014 Elsevier Ltd. All rights reserved.
Acknowledgements
The authors would like to thank colleagues at Mundipharma Research Limited (Cambridge, UK) who conducted the pooled analysis, and Oxford PharmaGenesis™ Limited (Oxford, UK) who provided medical writing services on behalf of Mundipharma Research Limited. Studies 1–4 were sponsored by Skyepharma (Muttenz, Switzerland). Study 5 was sponsored by Mundipharma Research Limited (Cambridge, UK).
PY - 2015/2
Y1 - 2015/2
N2 - BACKGROUND: Fluticasone propionate and formoterol fumarate have been combined in a single inhaler (fluticasone/formoterol; flutiform(®)) for the maintenance treatment of asthma. This pooled analysis assessed the efficacy of fluticasone/formoterol versus fluticasone in patients who previously received inhaled corticosteroids.METHODS: Data were pooled from five randomised studies in patients with asthma (aged ≥12 years) treated for 8 or 12 weeks with fluticasone/formoterol (100/10, 250/10 or 500/20 μg b.i.d.; n = 528 delivered via pMDI) or fluticasone alone (100, 250 or 500 μg b.i.d.; n = 527).RESULTS: Fluticasone/formoterol provided significantly greater increases than fluticasone alone in mean morning forced expiratory volume in 1 second (FEV1) from pre-dose at baseline to 2 hours post-dose at study end (least-squares mean [LSM] treatment difference: 0.146L; p < 0.001) and in pre-dose FEV1 from baseline to study end (LSM treatment difference: 0.048 L; p = 0.043). Compared with fluticasone, fluticasone/formoterol provided greater increases in the percentage of asthma control days (no symptoms, no rescue medication use and no sleep disturbance due to asthma) from baseline to study end (LSM treatment difference: 8.6%; p < 0.001), and was associated with a lower annualised rate of exacerbations (rate ratio: 0.71; p = 0.014).CONCLUSIONS: In summary, fluticasone/formoterol provides clinically significant improvements in lung function and asthma control measures, with a lower incidence of exacerbations than fluticasone alone.
AB - BACKGROUND: Fluticasone propionate and formoterol fumarate have been combined in a single inhaler (fluticasone/formoterol; flutiform(®)) for the maintenance treatment of asthma. This pooled analysis assessed the efficacy of fluticasone/formoterol versus fluticasone in patients who previously received inhaled corticosteroids.METHODS: Data were pooled from five randomised studies in patients with asthma (aged ≥12 years) treated for 8 or 12 weeks with fluticasone/formoterol (100/10, 250/10 or 500/20 μg b.i.d.; n = 528 delivered via pMDI) or fluticasone alone (100, 250 or 500 μg b.i.d.; n = 527).RESULTS: Fluticasone/formoterol provided significantly greater increases than fluticasone alone in mean morning forced expiratory volume in 1 second (FEV1) from pre-dose at baseline to 2 hours post-dose at study end (least-squares mean [LSM] treatment difference: 0.146L; p < 0.001) and in pre-dose FEV1 from baseline to study end (LSM treatment difference: 0.048 L; p = 0.043). Compared with fluticasone, fluticasone/formoterol provided greater increases in the percentage of asthma control days (no symptoms, no rescue medication use and no sleep disturbance due to asthma) from baseline to study end (LSM treatment difference: 8.6%; p < 0.001), and was associated with a lower annualised rate of exacerbations (rate ratio: 0.71; p = 0.014).CONCLUSIONS: In summary, fluticasone/formoterol provides clinically significant improvements in lung function and asthma control measures, with a lower incidence of exacerbations than fluticasone alone.
KW - asthma
KW - combination therapy
KW - efficacy
KW - fluticasone propionate
KW - formoterol
U2 - 10.1016/j.rmed.2014.10.019
DO - 10.1016/j.rmed.2014.10.019
M3 - Article
C2 - 25575940
VL - 109
SP - 208
EP - 217
JO - Respiratory Medicine
JF - Respiratory Medicine
SN - 0954-6111
IS - 2
ER -