Efficacy of fluticasone propionate/formoterol fumarate in the treatment of asthma: A pooled analysis

Alberto Papi; David Price; Joaquin Sastre; Kirsten Kaiser; Mark Lomax; Tammy McIver; Sanjeeva Dissanayake

doi:10.1016/j.rmed.2014.10.019

Efficacy of fluticasone propionate/formoterol fumarate in the treatment of asthma: A pooled analysis

Alberto Papi, David Price, Joaquin Sastre, Kirsten Kaiser, Mark Lomax, Tammy McIver, Sanjeeva Dissanayake

Research output: Contribution to journal › Article › peer-review

7 Citations (Scopus)

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.

Original language	English
Pages (from-to)	208-217
Number of pages	10
Journal	Respiratory Medicine
Volume	109
Issue number	2
Early online date	3 Dec 2014
DOIs	https://doi.org/10.1016/j.rmed.2014.10.019
Publication status	Published - Feb 2015

Bibliographical note

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).

Keywords

asthma
combination therapy
efficacy
fluticasone propionate
formoterol

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title = "Efficacy of fluticasone propionate/formoterol fumarate in the treatment of asthma: A pooled analysis",

abstract = "BACKGROUND: Fluticasone propionate and formoterol fumarate have been combined in a single inhaler (fluticasone/formoterol; flutiform({\textregistered})) 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.",

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author = "Alberto Papi and David Price and Joaquin Sastre and Kirsten Kaiser and Mark Lomax and Tammy McIver and Sanjeeva Dissanayake",

note = "Copyright {\textcopyright} 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{\texttrademark} 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).",

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doi = "10.1016/j.rmed.2014.10.019",

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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).

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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

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DO - 10.1016/j.rmed.2014.10.019

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JO - Respiratory Medicine

JF - Respiratory Medicine

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ER -

Efficacy of fluticasone propionate/formoterol fumarate in the treatment of asthma: A pooled analysis

Abstract

Bibliographical note

Keywords

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