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

 

Show simple item record

dc.contributor.author Lötvall, Jan
dc.contributor.author Bateman, Eric D
dc.contributor.author Busse, William W
dc.contributor.author O’Byrne, Paul M
dc.contributor.author Woodcock, Ashley
dc.contributor.author Toler, William T
dc.contributor.author Jacques, Loretta
dc.contributor.author Goldfrad, Caroline
dc.contributor.author Bleecker, Eugene R
dc.date.accessioned 2015-02-13T14:01:42Z
dc.date.available 2015-02-13T14:01:42Z
dc.date.issued 2014-06-13
dc.identifier.citation Lötvall, 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.issn 1477-5751 en_ZA
dc.identifier.uri http://hdl.handle.net/11427/12477
dc.identifier.uri http://dx.doi.org/10.1186/1477-5751-13-9
dc.description.abstract 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. en_ZA
dc.language eng en_ZA
dc.publisher BioMed Central en_ZA
dc.rights Creative Commons Attribution 4.0 International (CC BY 4.0) *
dc.rights.uri http://creativecommons.org/licenses/by/4.0/ en_ZA
dc.source Journal of Negative Results in BioMedicine en_ZA
dc.source.uri http://www.jnrbm.com/
dc.subject.other Asthma en_ZA
dc.subject.other Bronchodilators en_ZA
dc.subject.other Long-acting beta agonist, en_ZA
dc.subject.other Lung function en_ZA
dc.subject.other Placebo response en_ZA
dc.title Comparison of vilanterol, a novel long-acting beta2 agonist, with placebo and a salmeterol reference arm in asthma uncontrolled by inhaled corticosteroids en_ZA
dc.type Journal Article en_ZA
dc.date.updated 2015-01-15T17:58:34Z
dc.language.rfc3066 en
dc.rights.holder Lötvall et al.; licensee BioMed Central Ltd.
uct.type.publication Research en_ZA
uct.type.resource Article en_ZA
dc.publisher.institution University of Cape Town
dc.publisher.faculty Faculty of Health Sciences en_ZA
dc.publisher.department Department of Medicine en_ZA
uct.type.filetype Text
uct.type.filetype Image
dc.identifier.apacitation Lötvall, 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/11427/12477 en_ZA
dc.identifier.chicagocitation Lötvall, 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/11427/12477 en_ZA
dc.identifier.vancouvercitation Lötvall 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.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


Files in this item

This item appears in the following Collection(s)

Show simple item record

Creative Commons Attribution 4.0 International (CC BY 4.0) Except where otherwise noted, this item's license is described as Creative Commons Attribution 4.0 International (CC BY 4.0)