Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma

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dc.contributor.authorWoodcock, Ashleyen_ZA
dc.contributor.authorBleecker, Eugene Ren_ZA
dc.contributor.authorBusse, William Wen_ZA
dc.contributor.authorLotvall, Janen_ZA
dc.contributor.authorSnowise, Neil Gen_ZA
dc.contributor.authorFrith, Lucyen_ZA
dc.contributor.authorJacques, Lorettaen_ZA
dc.contributor.authorHaumann, Bretten_ZA
dc.contributor.authorBateman, Eric Den_ZA
dc.date.accessioned2015-11-18T04:01:16Z
dc.date.available2015-11-18T04:01:16Z
dc.date.issued2011en_ZA
dc.description.abstractBACKGROUND: Inhaled corticosteroids are the recommended first-line treatment for asthma but adherence to therapy is suboptimal. The objectives of this study were to compare the efficacy and safety of once-daily (OD) evening and twice-daily (BD) regimens of the novel inhaled corticosteroid fluticasone furoate (FF) in asthma patients. METHODS: Patients with moderate asthma (age [greater than or equal to] 12 years; pre-bronchodilator forced expiratory volume in 1 second (FEV1) 40-85% predicted; FEV1 reversibility of [greater than or equal to] 12% and [greater than or equal to] 200 ml) were randomized to FF or fluticasone propionate (FP) regimens in a double-blind, crossover study. Patients were not permitted to have used any ICS for [greater than or equal to] 8 weeks prior to enrolment and subsequently received doses of FF or FP 200 mug OD, FF or FP 100 mug BD and matching placebo by inhalation for 28 days each. Primary endpoint was Day 28 evening pre-dose (trough) FEV1; non-inferiority of FF 200 mug OD and FF 100 mug BD was assessed, as was superiority of all active treatment relative to placebo. Adverse events (AEs) and 24-hour urinary cortisol excretion were assessed. RESULTS: The intent-to-treat population comprised 147 (FF) and 43 (FP) patients. On Day 28, pre-dose FEV1 showed FF 200 mug OD to be non-inferior (pre-defined limit -110 ml) to FF 100 mug BD (mean treatment difference 11 ml; 95% CI: -35 to +56 ml); all FF and FP regimens were significantly superior to placebo (p [less than or equal to] 0.02). AEs were similar to placebo; no serious AEs were reported. Urinary cortisol excretion at Day 28 for FF was lower than placebo (ratios: 200 mug OD, 0.75; 100 mug BD, 0.84; p [less than or equal to] 0.02). CONCLUSIONS: FF 200 mug OD in the evening is an efficacious and well tolerated treatment for asthma patients and is not inferior to the same total BD dose.TRIAL REGISTRATION:Clinicaltrials.gov; NCT00766090.en_ZA
dc.identifier.apacitationWoodcock, A., Bleecker, E. R., Busse, W. W., Lotvall, J., Snowise, N. G., Frith, L., ... Bateman, E. D. (2011). Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma. <i>Respiratory Research</i>, http://hdl.handle.net/11427/15096en_ZA
dc.identifier.chicagocitationWoodcock, Ashley, Eugene R Bleecker, William W Busse, Jan Lotvall, Neil G Snowise, Lucy Frith, Loretta Jacques, Brett Haumann, and Eric D Bateman "Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma." <i>Respiratory Research</i> (2011) http://hdl.handle.net/11427/15096en_ZA
dc.identifier.citationWoodcock, A., Bleecker, E. R., Busse, W. W., Lötvall, J., Snowise, N. G., Frith, L., ... & Bateman, E. D. (2011). Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma. Respir Res, 12(160), 10-1186.en_ZA
dc.identifier.ris TY - Journal Article AU - Woodcock, Ashley AU - Bleecker, Eugene R AU - Busse, William W AU - Lotvall, Jan AU - Snowise, Neil G AU - Frith, Lucy AU - Jacques, Loretta AU - Haumann, Brett AU - Bateman, Eric D AB - BACKGROUND: Inhaled corticosteroids are the recommended first-line treatment for asthma but adherence to therapy is suboptimal. The objectives of this study were to compare the efficacy and safety of once-daily (OD) evening and twice-daily (BD) regimens of the novel inhaled corticosteroid fluticasone furoate (FF) in asthma patients. METHODS: Patients with moderate asthma (age [greater than or equal to] 12 years; pre-bronchodilator forced expiratory volume in 1 second (FEV1) 40-85% predicted; FEV1 reversibility of [greater than or equal to] 12% and [greater than or equal to] 200 ml) were randomized to FF or fluticasone propionate (FP) regimens in a double-blind, crossover study. Patients were not permitted to have used any ICS for [greater than or equal to] 8 weeks prior to enrolment and subsequently received doses of FF or FP 200 mug OD, FF or FP 100 mug BD and matching placebo by inhalation for 28 days each. Primary endpoint was Day 28 evening pre-dose (trough) FEV1; non-inferiority of FF 200 mug OD and FF 100 mug BD was assessed, as was superiority of all active treatment relative to placebo. Adverse events (AEs) and 24-hour urinary cortisol excretion were assessed. RESULTS: The intent-to-treat population comprised 147 (FF) and 43 (FP) patients. On Day 28, pre-dose FEV1 showed FF 200 mug OD to be non-inferior (pre-defined limit -110 ml) to FF 100 mug BD (mean treatment difference 11 ml; 95% CI: -35 to +56 ml); all FF and FP regimens were significantly superior to placebo (p [less than or equal to] 0.02). AEs were similar to placebo; no serious AEs were reported. Urinary cortisol excretion at Day 28 for FF was lower than placebo (ratios: 200 mug OD, 0.75; 100 mug BD, 0.84; p [less than or equal to] 0.02). CONCLUSIONS: FF 200 mug OD in the evening is an efficacious and well tolerated treatment for asthma patients and is not inferior to the same total BD dose.TRIAL REGISTRATION:Clinicaltrials.gov; NCT00766090. DA - 2011 DB - OpenUCT DO - 10.1186/1465-9921-12-160 DP - University of Cape Town J1 - Respiratory Research LK - https://open.uct.ac.za PB - University of Cape Town PY - 2011 T1 - Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma TI - Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma UR - http://hdl.handle.net/11427/15096 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/15096
dc.identifier.urihttp://dx.doi.org/10.1186/1465-9921-12-160
dc.identifier.vancouvercitationWoodcock A, Bleecker ER, Busse WW, Lotvall J, Snowise NG, Frith L, et al. Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma. Respiratory Research. 2011; http://hdl.handle.net/11427/15096.en_ZA
dc.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentDepartment of Medicineen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution Licenseen_ZA
dc.rights.holder2011 Woodcock et al; licensee BioMed Central Ltd.en_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceRespiratory Researchen_ZA
dc.source.urihttp://www.respiratory-research.com/en_ZA
dc.subject.otherAsthmaen_ZA
dc.subject.otherfluticasone furoateen_ZA
dc.subject.otherinhaled corticosteroiden_ZA
dc.subject.otheronce dailyen_ZA
dc.subject.otherefficacyen_ZA
dc.subject.othersafetyen_ZA
dc.titleFluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthmaen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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