Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial
| dc.contributor.author | O’Byrne, Paul M | |
| dc.contributor.author | Woodcock, Ashley | |
| dc.contributor.author | Bleecker, Eugene R | |
| dc.contributor.author | Bateman, Eric D | |
| dc.contributor.author | Lötvall, Jan | |
| dc.contributor.author | Forth, Richard | |
| dc.contributor.author | Medley, Hilary | |
| dc.contributor.author | Jacques, Loretta | |
| dc.contributor.author | Busse, William W | |
| dc.date.accessioned | 2015-07-30T03:58:03Z | |
| dc.date.available | 2015-07-30T03:58:03Z | |
| dc.date.issued | 2014-08-11 | |
| dc.date.updated | 2015-01-15T17:59:15Z | |
| dc.description.abstract | Abstract Background Fluticasone furoate (FF) is a novel, once-daily inhaled corticosteroid (ICS) that has been shown to improve lung function vs. placebo in asthma patients. This study evaluated the efficacy and safety of FF 50 mcg compared with placebo in asthma patients uncontrolled by non-ICS therapy. Methods This 12-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study randomized 248 patients (aged ≥12 years) to once-daily FF 50 mcg administered via the ELLIPTA™a dry powder inhaler or placebo. The primary endpoint was change from baseline in pre-dose evening trough forced expiratory volume in one second (FEV1). Secondary endpoints were change from baseline in percentage of rescue-free 24-h periods (powered), evening and morning peak expiratory flow, symptom-free 24-h periods and withdrawals due to lack of efficacy. Other endpoints included Asthma Control Test™, Asthma Quality of Life Questionnaire and ELLIPTA ease of use questions. Safety was assessed throughout the study. Results There was a significant difference in evening trough FEV1 between FF 50 mcg and placebo (treatment difference: 120 mL; p = 0.012). There was also a significant difference in rescue-free 24-h periods (11.6%; p = 0.004) vs. placebo. There were numerically greater improvements with FF vs. placebo for all remaining secondary endpoints. The incidence of adverse events was lower with FF (31%) than with placebo (38%); few were treatment-related (FF 50 mcg: n = 1, <1%; placebo: n = 4, 3%). Conclusion FF 50 mcg once daily significantly improved FEV1 and percentage of rescue-free 24-h periods experienced over 12 weeks vs. placebo, and was well tolerated. Trial registration www.clinicaltrials.gov , registration number: NCT01436071 | |
| dc.identifier.apacitation | , Woodcock, A., Bleecker, E. R., Bateman, E. D., Lötvall, J., Forth, R., ... Busse, W. W. (2014). Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial. <i>Respiratory Research</i>, http://hdl.handle.net/11427/13600 | en_ZA |
| dc.identifier.chicagocitation | , Ashley Woodcock, Eugene R Bleecker, Eric D Bateman, Jan Lötvall, Richard Forth, Hilary Medley, Loretta Jacques, and William W Busse "Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial." <i>Respiratory Research</i> (2014) http://hdl.handle.net/11427/13600 | en_ZA |
| dc.identifier.citation | O’Byrne, P. M., Woodcock, A., Bleecker, E. R., Bateman, E. D., Lötvall, J., Forth, R., ... & Busse, W. W. (2014). Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial. Respiratory research, 15(1), 88. | |
| dc.identifier.ris | TY - Journal Article AU - O’Byrne, Paul M AU - Woodcock, Ashley AU - Bleecker, Eugene R AU - Bateman, Eric D AU - Lötvall, Jan AU - Forth, Richard AU - Medley, Hilary AU - Jacques, Loretta AU - Busse, William W AB - Abstract Background Fluticasone furoate (FF) is a novel, once-daily inhaled corticosteroid (ICS) that has been shown to improve lung function vs. placebo in asthma patients. This study evaluated the efficacy and safety of FF 50 mcg compared with placebo in asthma patients uncontrolled by non-ICS therapy. Methods This 12-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study randomized 248 patients (aged ≥12 years) to once-daily FF 50 mcg administered via the ELLIPTA™a dry powder inhaler or placebo. The primary endpoint was change from baseline in pre-dose evening trough forced expiratory volume in one second (FEV1). Secondary endpoints were change from baseline in percentage of rescue-free 24-h periods (powered), evening and morning peak expiratory flow, symptom-free 24-h periods and withdrawals due to lack of efficacy. Other endpoints included Asthma Control Test™, Asthma Quality of Life Questionnaire and ELLIPTA ease of use questions. Safety was assessed throughout the study. Results There was a significant difference in evening trough FEV1 between FF 50 mcg and placebo (treatment difference: 120 mL; p = 0.012). There was also a significant difference in rescue-free 24-h periods (11.6%; p = 0.004) vs. placebo. There were numerically greater improvements with FF vs. placebo for all remaining secondary endpoints. The incidence of adverse events was lower with FF (31%) than with placebo (38%); few were treatment-related (FF 50 mcg: n = 1, <1%; placebo: n = 4, 3%). Conclusion FF 50 mcg once daily significantly improved FEV1 and percentage of rescue-free 24-h periods experienced over 12 weeks vs. placebo, and was well tolerated. Trial registration www.clinicaltrials.gov , registration number: NCT01436071 DA - 2014-08-11 DB - OpenUCT DO - 10.1186/s12931-014-0088-z DP - University of Cape Town J1 - Respiratory Research LK - https://open.uct.ac.za PB - University of Cape Town PY - 2014 T1 - Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial TI - Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial UR - http://hdl.handle.net/11427/13600 ER - | en_ZA |
| dc.identifier.uri | http://hdl.handle.net/11427/13600 | |
| dc.identifier.uri | http://dx.doi.org/10.1186/s12931-014-0088-z | |
| dc.identifier.vancouvercitation | , Woodcock A, Bleecker ER, Bateman ED, Lötvall J, Forth R, et al. Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial. Respiratory Research. 2014; http://hdl.handle.net/11427/13600. | en_ZA |
| dc.language.rfc3066 | en | |
| dc.publisher.department | Department of Medicine | en_ZA |
| dc.publisher.faculty | Faculty of Health Sciences | en_ZA |
| dc.publisher.institution | University of Cape Town | |
| dc.rights | This is an Open Access article distributed under the terms of the Creative Commons Attribution License | * |
| dc.rights.holder | O'Byrne et al.; licensee BioMed Central Ltd. | |
| dc.rights.uri | http://creativecommons.org/licenses/by/4.0 | * |
| dc.source | Respiratory Research | en_ZA |
| dc.source.uri | http://www.respiratory-research.com/ | |
| dc.subject.other | Fluticasone furoate | en_ZA |
| dc.subject.other | Inhaled corticosteroid | en_ZA |
| dc.subject.other | Lung function | en_ZA |
| dc.title | Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial | |
| dc.type | Journal Article | en_ZA |
| uct.type.filetype | ||
| uct.type.filetype | Text | |
| uct.type.filetype | Image | |
| uct.type.publication | Research | en_ZA |
| uct.type.resource | Article | en_ZA |