Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Azithromycin as Add-On Therapy for Asthma

Lancet; ePub 2017 Jul 4; Gibson, et al

When treated with oral azithromycin for 48 weeks, adults with persistent symptomatic asthma experienced fewer asthma exacerbations and improved quality of life, a recent study found.

The randomized, double-blind, placebo controlled parallel group trial included 420 adult patients aged ≥18 years between June 12, 2009 and January 31, 2015, with symptomatic asthma despite use of inhaled corticosteroid and long-acting bronchodilator and who had no hearing impairment or abnormal prolongation of the corrected QT interval. Patients were randomly assigned 1:1 to receive azithromycin 500 mg (n=213) or placebo (n=207) 3 times per week for 48 weeks. Researchers found:

  • Azithromycin reduced asthma exacerbations compared with placebo (1.07 vs 1.86 per patient year; incidence rate ratio [IRR] 0.59).
  • The proportion of patients experiencing at least 1 asthma exacerbation was reduced by azithromycin treatment.
  • Azithromycin significantly improved asthma-related quality of life.


Gibson PG, Yang IA, Upham JW, et al. Effect of azithromycin on asthma exacerbations and quality of life in adults with persistent uncontrolled asthma (AMEZES): a randomized, double-blind, placebo-controlled trial. [Published online ahead of print July 4, 2017]. Lancet. doi:10.1016/S0140-6736(17)31281-3.


Despite the availability of excellent treatments like inhaled corticosteroids and long acting bronchodilators, there are many patients who still have sub-optimal control of their asthma. The first step in evaluating sub-optimal asthma control should be to inquire about adherence to taking the prescribed inhaler as directed. If a patient is taking their combination ICS/LABA inhaler, and potential environmental and allergic contributors to asthma have been assessed, the available agents include anti-IgE therapy with omalizumab and the new class of anti-IL5 agents (mepolizumab and reslizumab). This randomized blinded study of azithromycin convincingly shows a substantial benefit to azithromycin 500 mg 3 times a week in decreasing both severe and non-severe exacerbations by about 40%, as well as improving asthma-related quality of life. This fits with and extends previous studies that suggest macrolides have anti-inflammatory, antibacterial, and antiviral effects.1 This study is solid enough to consider azithromycin as a potential therapeutic option, recognizing that it is not FDA approved for this indication, for patients who continue to have symptoms despite current maximal therapy for asthma. —Neil Skolnik, MD

  1. Brusselle GG, Joos G. Is there a role for macrolides in severe asthma? Curr Opin Pulm Med. 2014;95–102.

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FDA Approves Fasenra for Severe Eosinophilic Asthma, AstraZeneca news release; 2017 Nov 14

Can Vitamin D Prevent Asthma Exacerbations?, Lancet Respir Med; ePub 2017 Oct 3; Jolliffee, et al

Early-Life Environmental Asthma Risk in Children, J Allergy Clin Immunol; ePub 2017 Sep 19; O’Connor, et al

Tezepelumab and Uncontrolled Asthma in Adults , N Engl J Med; ePub 2017 Sep 7; Corren, et al

Is Global Asthma Mortality on the Decline?, Lancet; ePub 2017 Aug 7; Ebmeier, et al