Comparison of vilanterol, a novel long-acting beta2 agonist, with placebo and a salmeterol reference arm in asthma uncontrolled by inhaled corticosteroids

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dc.contributor.authorLötvall, Jan
dc.contributor.authorBateman, Eric D
dc.contributor.authorBusse, William W
dc.contributor.authorO’Byrne, Paul M
dc.contributor.authorWoodcock, Ashley
dc.contributor.authorToler, William T
dc.contributor.authorJacques, Loretta
dc.contributor.authorGoldfrad, Caroline
dc.contributor.authorBleecker, Eugene R
dc.date.accessioned2015-02-13T14:01:42Z
dc.date.available2015-02-13T14:01:42Z
dc.date.issued2014-06-13
dc.date.updated2015-01-15T17:58:34Z
dc.description.abstractBackground: Current maintenance therapies for asthma require twice-daily dosing. Vilanterol (VI) is a novel long-acting beta2 agonist, under development in combination with fluticasone furoate, a new inhaled corticosteroid (ICS). Findings from a previous 4-week study suggested that VI has inherent 24-hour activity and is therefore suitable for once-daily dosing. The study described here was a double-blind, double-dummy, randomised, placebo-controlled trial, the aim of which was to assess the efficacy of once-daily VI compared with placebo in patients with persistent asthma. The primary endpoint was change from baseline in 24-hour weighted mean forced expiratory volume in 1 second after 12 weeks of treatment vs. placebo. An active control arm received salmeterol (SAL) twice daily. All patients were maintained on a stable background dose of ICS. Results: Patients (n = 347) received VI, placebo or SAL (1:1:1). For the primary endpoint, substantial improvements in lung function were seen with VI (359 ml), SAL (283 ml) and placebo (289 ml). There were no statistically significant treatment differences between either the VI (70 ml, P = 0.244) or SAL (-6 ml, P = 0.926) groups and placebo. Both active treatments were well tolerated, with similarly low rates of treatment-related adverse events compared with placebo. No treatment-related serious adverse events occurred. Conclusions: This study failed to show a treatment difference between VI and placebo for the primary endpoint, in the presence of a placebo response of unforeseen magnitude. Because the placebo response was so large, it is not possible to draw meaningful conclusions from the data. The reason for this magnitude of effect is unclear but it may reflect increased compliance with the anti-inflammatory therapy regimen during the treatment period. Trial registration: NCT01181895 at ClinicalTrials.gov.en_ZA
dc.identifier.apacitationLötvall, J., Bateman, E. D., Busse, W. W., , Woodcock, A., Toler, W. T., ... Bleecker, E. R. (2014). Comparison of vilanterol, a novel long-acting beta2 agonist, with placebo and a salmeterol reference arm in asthma uncontrolled by inhaled corticosteroids. <i>Journal of Negative Results in BioMedicine</i>, http://hdl.handle.net/11427/12477en_ZA
dc.identifier.chicagocitationLötvall, Jan, Eric D Bateman, William W Busse, , Ashley Woodcock, William T Toler, Loretta Jacques, Caroline Goldfrad, and Eugene R Bleecker "Comparison of vilanterol, a novel long-acting beta2 agonist, with placebo and a salmeterol reference arm in asthma uncontrolled by inhaled corticosteroids." <i>Journal of Negative Results in BioMedicine</i> (2014) http://hdl.handle.net/11427/12477en_ZA
dc.identifier.citationLötvall, J., Bateman, E. D., Busse, W. W., O’Byrne, P. M., Woodcock, A., Toler, W. T., ... & Bleecker, E. R. (2014). Comparison of vilanterol, a novel long-acting beta2 agonist, with placebo and a salmeterol reference arm in asthma uncontrolled by inhaled corticosteroids. Journal of negative results in biomedicine, 13(1), 9.en_ZA
dc.identifier.issn1477-5751en_ZA
dc.identifier.ris TY - Journal Article AU - Lötvall, Jan AU - Bateman, Eric D AU - Busse, William W AU - O’Byrne, Paul M AU - Woodcock, Ashley AU - Toler, William T AU - Jacques, Loretta AU - Goldfrad, Caroline AU - Bleecker, Eugene R AB - Background: Current maintenance therapies for asthma require twice-daily dosing. Vilanterol (VI) is a novel long-acting beta2 agonist, under development in combination with fluticasone furoate, a new inhaled corticosteroid (ICS). Findings from a previous 4-week study suggested that VI has inherent 24-hour activity and is therefore suitable for once-daily dosing. The study described here was a double-blind, double-dummy, randomised, placebo-controlled trial, the aim of which was to assess the efficacy of once-daily VI compared with placebo in patients with persistent asthma. The primary endpoint was change from baseline in 24-hour weighted mean forced expiratory volume in 1 second after 12 weeks of treatment vs. placebo. An active control arm received salmeterol (SAL) twice daily. All patients were maintained on a stable background dose of ICS. Results: Patients (n = 347) received VI, placebo or SAL (1:1:1). For the primary endpoint, substantial improvements in lung function were seen with VI (359 ml), SAL (283 ml) and placebo (289 ml). There were no statistically significant treatment differences between either the VI (70 ml, P = 0.244) or SAL (-6 ml, P = 0.926) groups and placebo. Both active treatments were well tolerated, with similarly low rates of treatment-related adverse events compared with placebo. No treatment-related serious adverse events occurred. Conclusions: This study failed to show a treatment difference between VI and placebo for the primary endpoint, in the presence of a placebo response of unforeseen magnitude. Because the placebo response was so large, it is not possible to draw meaningful conclusions from the data. The reason for this magnitude of effect is unclear but it may reflect increased compliance with the anti-inflammatory therapy regimen during the treatment period. Trial registration: NCT01181895 at ClinicalTrials.gov. DA - 2014-06-13 DB - OpenUCT DO - 10.1186/1477-5751-13-9 DP - University of Cape Town J1 - Journal of Negative Results in BioMedicine LK - https://open.uct.ac.za PB - University of Cape Town PY - 2014 SM - 1477-5751 T1 - Comparison of vilanterol, a novel long-acting beta2 agonist, with placebo and a salmeterol reference arm in asthma uncontrolled by inhaled corticosteroids TI - Comparison of vilanterol, a novel long-acting beta2 agonist, with placebo and a salmeterol reference arm in asthma uncontrolled by inhaled corticosteroids UR - http://hdl.handle.net/11427/12477 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/12477
dc.identifier.urihttp://dx.doi.org/10.1186/1477-5751-13-9
dc.identifier.vancouvercitationLötvall J, Bateman ED, Busse WW, , Woodcock A, Toler WT, et al. Comparison of vilanterol, a novel long-acting beta2 agonist, with placebo and a salmeterol reference arm in asthma uncontrolled by inhaled corticosteroids. Journal of Negative Results in BioMedicine. 2014; http://hdl.handle.net/11427/12477.en_ZA
dc.languageengen_ZA
dc.language.rfc3066en
dc.publisherBioMed Centralen_ZA
dc.publisher.departmentDepartment of Medicineen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsCreative Commons Attribution 4.0 International (CC BY 4.0)*
dc.rights.holderLötvall et al.; licensee BioMed Central Ltd.
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_ZA
dc.sourceJournal of Negative Results in BioMedicineen_ZA
dc.source.urihttp://www.jnrbm.com/
dc.subject.otherAsthmaen_ZA
dc.subject.otherBronchodilatorsen_ZA
dc.subject.otherLong-acting beta agonist,en_ZA
dc.subject.otherLung functionen_ZA
dc.subject.otherPlacebo responseen_ZA
dc.titleComparison of vilanterol, a novel long-acting beta2 agonist, with placebo and a salmeterol reference arm in asthma uncontrolled by inhaled corticosteroidsen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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