Controlled Trial of Budesonide–Formoterol as Needed for Mild Asthma

Beasley, Richard; Holliday, Mark; Reddel, Helen K.; Braithwaite, Irene; Ebmeier, Stefan; Hancox, Robert J.; Harrison, Tim; Houghton, Claire; Oldfield, Karen; Papi, Alberto; Pavord, Ian D.; Williams, Mathew; Weatherall, Mark

Abstract

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

Citation

Beasley, R., Holliday, M., Reddel, H. K., Braithwaite, I., Ebmeier, S., Hancox, R. J., …Weatherall, M. (2019). Controlled Trial of Budesonide–Formoterol as Needed for Mild Asthma. New England Journal of Medicine, 380(21), 1-11. https://doi.org/10.1056/nejmoa1901963

• Journal Article Type: Article
• Acceptance Date: Apr 19, 2019
• Online Publication Date: May 19, 2019
• Publication Date: May 23, 2019
• Deposit Date: Jun 19, 2019
• Publicly Available Date: Nov 20, 2019
• Journal: New England Journal of Medicine
• Print ISSN: 0028-4793
• Electronic ISSN: 1533-4406
• Publisher: Massachusetts Medical Society
• Peer Reviewed: Peer Reviewed
• Volume: 380
• Issue: 21
• Pages: 1-11
• DOI: https://doi.org/10.1056/nejmoa1901963
• Keywords: General Medicine
• Public URL: https://nottingham-repository.worktribe.com/output/2208247
• Publisher URL: https://www.nejm.org/doi/full/10.1056/NEJMoa1901963