BibTex format
@article{O'Byrne:2017:10.1186/s13063-016-1731-4,
author = {O'Byrne, PM and FitzGerald, JM and Zhong, N and Bateman, E and Barnes, PJ and Keen, C and Almqvist, G and Pemberton, K and Jorup, C and Ivanov, S and Reddel, HK},
doi = {10.1186/s13063-016-1731-4},
journal = {Trials},
title = {The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given 'as needed' in mild asthma: study protocols for two randomised controlled trials},
url = {http://dx.doi.org/10.1186/s13063-016-1731-4},
volume = {18},
year = {2017}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - Background: In many patients with mild asthma, the low frequency of symptoms and the episodic nature ofexacerbations make adherence to regular maintenance treatment difficult. This often leads to over-reliance onshort-acting β2-agonist (SABA) reliever medication and under-treatment of the underlying inflammation, with poorcontrol of asthma symptoms and increased risk of exacerbations. The use of budesonide/formoterol ‘as needed’ inresponse to symptoms may represent an alternative treatment option for patients with mild asthma.Methods/design: The SYmbicort Given as needed in Mild Asthma (SYGMA) programme consists of two 52-week,double-blind, randomised, multicentre, parallel-group, phase 3 trials of patients aged 12 years and older with aclinical diagnosis of asthma for at least 6 months, who would qualify for treatment with regular inhaledcorticosteroids (ICS). SYGMA1 aims to recruit 3750 patients who will be randomised to placebo twice daily (bid)plus as-needed budesonide/formoterol 160/4.5 μg, placebo bid plus as-needed terbutaline 0.4 mg, or budesonide200 μg bid plus as-needed terbutaline 0.4 mg. The primary objective is to demonstrate the superiority of as-neededbudesonide/formoterol over as-needed terbutaline for asthma control, as measured by well-controlled asthmaweeks; a secondary objective is to establish the noninferiority of as-needed budesonide/formoterol versusmaintenance budesonide plus as-needed terbutaline using the same outcome measure. SYGMA2 aims to recruit4114 patients who will be randomised to placebo bid plus as-needed budesonide/formoterol 160/4.5 μg, orbudesonide 200 μg bid plus as-needed terbutaline 0.4 mg. The primary objective is to demonstrate thenoninferiority of as-needed budesonide/formoterol over budesonide bid plus as-needed terbutaline as measured bythe annualised severe exacerbation rate. In both studies, use of all blinded study inhalers will be recordedelectronically using Turbuhaler® Usage Monito
AU - O'Byrne,PM
AU - FitzGerald,JM
AU - Zhong,N
AU - Bateman,E
AU - Barnes,PJ
AU - Keen,C
AU - Almqvist,G
AU - Pemberton,K
AU - Jorup,C
AU - Ivanov,S
AU - Reddel,HK
DO - 10.1186/s13063-016-1731-4
PY - 2017///
SN - 1745-6215
TI - The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given 'as needed' in mild asthma: study protocols for two randomised controlled trials
T2 - Trials
UR - http://dx.doi.org/10.1186/s13063-016-1731-4
UR - http://hdl.handle.net/10044/1/53767
VL - 18
ER -