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@article{Bateman:2018:10.1056/NEJMoa1715275,
author = {Bateman, ED and Reddel, HK and O'Byrne, PM and Barnes, PJ and Zhong, N and Keen, C and Jorup, C and Lamarca, R and Siwek-Posluszna, A and FitzGerald, JM},
doi = {10.1056/NEJMoa1715275},
journal = {New England Journal of Medicine},
pages = {1877--1887},
title = {As-needed budesonide-formoterol versus maintenance budesonide in mild asthma},
url = {http://dx.doi.org/10.1056/NEJMoa1715275},
volume = {378},
year = {2018}
}

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TY  - JOUR
AB  - BackgroundPatients with mild asthma often rely on inhaled short-acting β2-agonists for symptom relief and have poor adherence to maintenance therapy. Another approach might be for patients to receive a fast-acting reliever plus an inhaled glucocorticoid component on an as-needed basis to address symptoms and exacerbation risk.MethodsWe conducted a 52-week, double-blind, multicenter trial involving patients 12 years of age or older who had mild asthma and were eligible for treatment with regular inhaled glucocorticoids. Patients were randomly assigned to receive twice-daily placebo plus budesonide–formoterol (200 μg of budesonide and 6 μg of formoterol) used as needed or budesonide maintenance therapy with twice-daily budesonide (200 μg) plus terbutaline (0.5 mg) used as needed. The primary analysis compared budesonide–formoterol used as needed with budesonide maintenance therapy with regard to the annualized rate of severe exacerbations, with a prespecified noninferiority limit of 1.2. Symptoms were assessed according to scores on the Asthma Control Questionnaire–5 (ACQ-5) on a scale from 0 (no impairment) to 6 (maximum impairment).ResultsA total of 4215 patients underwent randomization, and 4176 (2089 in the budesonide–formoterol group and 2087 in the budesonide maintenance group) were included in the full analysis set. Budesonide–formoterol used as needed was noninferior to budesonide maintenance therapy for severe exacerbations; the annualized rate of severe exacerbations was 0.11 (95% confidence interval [CI], 0.10 to 0.13) and 0.12 (95% CI, 0.10 to 0.14), respectively (rate ratio, 0.97; upper one-sided 95% confidence limit, 1.16). The median daily metered dose of inhaled glucocorticoid was lower in the budesonide–formoterol group (66 μg) than in the budesonide maintenance group (267 μg). The time to the first exacerbation was similar in the two groups (hazard ratio, 0.96; 95% CI, 0.78 to 1.17). The change
AU  - Bateman,ED
AU  - Reddel,HK
AU  - O'Byrne,PM
AU  - Barnes,PJ
AU  - Zhong,N
AU  - Keen,C
AU  - Jorup,C
AU  - Lamarca,R
AU  - Siwek-Posluszna,A
AU  - FitzGerald,JM
DO  - 10.1056/NEJMoa1715275
EP  - 1887
PY  - 2018///
SN  - 0028-4793
SP  - 1877
TI  - As-needed budesonide-formoterol versus maintenance budesonide in mild asthma
T2  - New England Journal of Medicine
UR  - http://dx.doi.org/10.1056/NEJMoa1715275
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000432299600005&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
VL  - 378
ER  -

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Professor Sir Peter Barnes, FRS, FMedSci

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