Alberto Papi1, David Price2, Joaquin Sastre3, Kirsten Kaiser4, Mark Lomax5, Tammy McIver6, Sanjeeva Dissanayake7. 1. Department of Clinical and Experimental Medicine, University of Ferrara, Ferrara, Italy. Electronic address: ppa@unife.it. 2. Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK. Electronic address: david@respiratoryresearch.org. 3. Fundacion Jimenez Diaz and CIBERES, Madrid, Spain. Electronic address: JSastre@fjd.es. 4. Skyepharma, Muttenz, Switzerland. Electronic address: K.Kaiser@skyepharma.com. 5. Mundipharma Research Limited, Cambridge, UK. Electronic address: Mark.Lomax@mundipharma-rd.eu. 6. Mundipharma Research Limited, Cambridge, UK. Electronic address: Tammy.McIver@mundipharma-rd.eu. 7. Mundipharma Research Limited, Cambridge, UK. Electronic address: Sanjeeva.Dissanayake@mundipharma-rd.eu.
Abstract
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.
RCT Entities:
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.