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 |