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BACKGROUND:In double-blind, placebo-controlled trials, budesonide-formoterol used on an as-needed basis resulted in a lower risk of severe exacerbation of asthma than as-needed use of a short-acting β2-agonist (SABA); the risk was similar to that of budesonide maintenance therapy plus as-needed SABA. The availability of data from clinical trials designed to better reflect clinical practice would be beneficial. METHODS:We conducted a 52-week, randomized, open-label, parallel-group, controlled trial involving adults with mild asthma. Patients were randomly assigned to one of three treatment groups: albuterol (100 μg, two inhalations from a pressurized metered-dose inhaler as needed for asthma symptoms) (albuterol group); budesonide (200 μg, one inhalation through a Turbuhaler twice daily) plus as-needed albuterol (budesonide maintenance group); or budesonide-formoterol (200 μg of budesonide and 6 μg of formoterol, one inhalation through a Turbuhaler as needed) (budesonide-formoterol group). Electronic monitoring of inhalers was used to measure medication use. The primary outcome was the annualized rate of asthma exacerbations. RESULTS:The analysis included 668 of 675 patients who underwent randomization. The annualized exacerbation rate in the budesonide-formoterol group was lower than that in the albuterol group (absolute rate, 0.195 vs. 0.400; relative rate, 0.49; 95% confidence interval [CI], 0.33 to 0.72; P<0.001) and did not differ significantly from the rate in the budesonide maintenance group (absolute rate, 0.195 in the budesonide-formoterol group vs. 0.175 in the budesonide maintenance group; relative rate, 1.12; 95% CI, 0.70 to 1.79; P = 0.65). The number of severe exacerbations was lower in the budesonide-formoterol group than in both the albuterol group (9 vs. 23; relative risk, 0.40; 95% CI, 0.18 to 0.86) and the budesonide maintenance group (9 vs. 21; relative risk, 0.44; 95% CI, 0.20 to 0.96). The mean (±SD) dose of inhaled budesonide was 107±109 μg per day in the budesonide-formoterol group and 222±113 μg per day in the budesonide maintenance group. The incidence and type of adverse events reported were consistent with those in previous trials and with reports in clinical use. CONCLUSIONS:In an open-label trial involving adults with mild asthma, budesonide-formoterol used as needed was superior to albuterol used as needed for the prevention of asthma exacerbations. (Funded by AstraZeneca and the Health Research Council of New Zealand; Novel START Australian New Zealand Clinical Trials Registry number, ACTRN12615000999538.).

Original publication

DOI

10.1056/nejmoa1901963

Type

Journal article

Journal

The New England journal of medicine

Publication Date

19/05/2019

Volume

380

Pages

2020 - 2030

Addresses

From the Medical Research Institute of New Zealand (R.B., M.H., I.B., S.E., C.H., K.O., M. Williams), the Capital and Coast District Health Board (R.B.), and the University of Otago Wellington (M. Weatherall), Wellington, the Department of Respiratory Medicine, Waikato Hospital, Hamilton (R.J.H.), and the Department of Preventive and Social Medicine, University of Otago, Dunedin (R.J.H.) - all in New Zealand; Woolcock Institute of Medical Research, University of Sydney, Sydney (H.K.R.); the Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham (T.H.), and the Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford (I.D.P.) - both in the United Kingdom; and the Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy (A.P.).

Keywords

Novel START Study Team, Humans, Asthma, Albuterol, Budesonide, Bronchodilator Agents, Drug Therapy, Combination, Administration, Inhalation, Metered Dose Inhalers, Adult, Aged, Middle Aged, Female, Male, Adrenergic beta-2 Receptor Agonists, Formoterol Fumarate