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As-Needed Budesonide–Formoterol versus Maintenance Budesonide in Mild Asthma

Eric D. Bateman;Helen K. Reddel;Paul M. O’Byrne;Peter J. Barnes;南山 钟;Christina Keen;Carin Jorup;Rosa Lamarca;Agnieszka Siwek-Posluszna;J. Mark FitzGerald

University of Cape Town;University of Sydney;Michael G. DeGroote School of Medicine;Imperial College London;Guangzhou Medical College;AstraZeneca;University of British Columbia

发表时间:2018-5-17

期 刊:New England Journal of Medicine

语 言:English

U R L: http://www.scopus.com/inward/record.url?scp=85047300745&partnerID=8YFLogxK

摘要

BACKGROUND Patients 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. METHODS We 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). RESULTS A 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 in ACQ-5 score showed a difference of 0.11 units (95% CI, 0.07 to 0.15) in favor of budesonide maintenance therapy. CONCLUSIONS In patients with mild asthma, budesonide–formoterol used as needed was noninferior to twice-daily budesonide with respect to the rate of severe asthma exacerbations during 52 weeks of treatment but was inferior in controlling symptoms. Patients in the budesonide–formoterol group had approximately one quarter of the inhaled glucocorticoid exposure of those in the budesonide maintenance group. (Funded by AstraZeneca; SYGMA 2 ClinicalTrials.gov number, NCT02224157.

相关科学

医学

被引量

期刊度量

Scopus度量

年份 CiteScore SJR SNIP
1996
1997
1998
1999 7.361 10.989
2000 8.367 10.43
2001 8.571 10.65
2002 9.315 11.39
2003 10.407 13.878
2004 11.349 13.963
2005 9.888 12.13
2006 10.173 11.886
2007 10.481 11.853
2008 11.386 11.487
2009 11.765 11.932
2010 13.149 11.382
2011 56 13.674 12.685
2012 60.2 13.984 13.287
2013 58 14.796 14.706
2014 57.3 16.259 13.935
2015 57.4 16.591 13.011
2016 61.1 18.009 12.685
2017 67.2 19.476 12.908
2018 73.1 19.524 13.73
2019 66.1 18.291 13.212
2020 76.1

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