Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone: no higher risk with the combo

Concerns remain about the safety of adding long-acting beta2-agonists to inhaled glucocorticoids for the treatment of asthma (ICS/LABA combo). These are the results of the postmarketing safety study mandated by the FDA, published in NEJM.

This multicenter, double-blind, 26-week study included 11,000 patients, 12 years of age or older, who had persistent asthma, and randomized them to receive budesonide–formoterol or budesonide alone.

The risk of an asthma exacerbation was 16.5% lower with budesonide–formoterol. Among adolescents and adults with moderate-to-severe asthma, treatment with budesonide–formoterol was associated with a lower risk of asthma exacerbations than budesonide and a similar risk of serious asthma-related events.


Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone. Stephen P. Peters et al. N Engl J Med 2016; 375:850-860, September 1, 2016.

The World Allergy Organization (WAO) Small Airways Working Group publishes a monthly "What's New?" summary and I have served as its editor since 2011. The summary features the top 3 asthma/small airways articles each month. The article above is a part of the project. The archive is here:

Image source: Image source: FDA and Wikipedia, public domain.

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