AZITHROMYCIN FOR ACUTE EXACERBATIONS OF ASTHMA: THE AZALEA RCT

FCAAIA Notes: This is yet another study showing that the use of antibiotics without proof or high suspicion of a bacterial infection is unwarranted.  I could go even farther and say it is inappropriate, as overuse of antibiotics increases resistance to antibiotics among bacteria and greatly increases medical costs.

That is not to say that we are not all guilty at times of over-prescribing.  Sometimes we suspect a bacterial infection when there is none.  Sometimes our patients are so sick or so uncomfortable we want to do everything we can think of to get them better as fast as possible.  And, sometimes we are coerced by patients who will only leave the office satisfied if they get an antibiotic. The point is that there is a time and place for antibiotics, but asthma flares are not.

(Source: https://www.doximity.com/doc_news/v2/entries/4749901 Sept. 24, 2016. Adapted from JAMA Intern Med. 2016;176(11):1630-1637)

Importance: Guidelines recommend against antibiotic use to treat asthma attacks. A study with telithromycin reported benefit, but adverse reactions limit its use.

Objective: To determine whether azithromycin added to standard care for asthma attacks in adults results in clinical benefit.

Design, Setting, and Participants: The Azithromycin Against Placebo in Exacerbations of Asthma (AZALEA) randomized, double-blind, placebo-controlled clinical trial, a United Kingdom–based multicenter study in adults requesting emergency care for acute asthma exacerbations, ran from September 2011 to April 2014. Adults with a history of asthma for more than 6 months were recruited within 48 hours of presentation to medical care with an acute deterioration in asthma control requiring a course of oral and/or systemic corticosteroids.

Interventions: Azithromycin 500 mg daily or matched placebo for 3 days.

Main Outcomes and Measures: The primary outcome was diary card symptom score 10 days after randomization, with a hypothesized treatment effect size of −0.3. Secondary outcomes were diary card symptom score, quality-of-life questionnaires, and lung function changes, all between exacerbation and day 10, and time to a 50% reduction in symptom score.

Results:  Of 4582 patients screened at 31 centers, 199 of a planned 380 were randomized within 48 hours of presentation. The major reason for nonrecruitment was receipt of antibiotics (2044 [44.6%] screened patients). Median time from presentation to drug administration was 22 hours (interquartile range, 14-28 hours). Exacerbation characteristics were well balanced across treatment arms and centers. The primary outcome asthma symptom scores were mean (SD), 4.14 (1.38) at exacerbation and 2.09 (1.71) at 10 days for the azithromycin group and 4.18 (1.48) and 2.20 (1.51) for the placebo group, respectively. Using multilevel modeling, there was no significant difference in symptom scores between azithromycin and placebo at day 10 (difference, −0.166; 95% CI, −0.670 to 0.337), nor on any day between exacerbation and day 10. No significant between-group differences were observed in quality-of-life questionnaires or lung function between exacerbation and day 10, or in time to 50% reduction in symptom score.

Conclusions and Relevance  In this randomized population, azithromycin treatment resulted in no statistically or clinically significant benefit. For each patient randomized, more than 10 were excluded because they had already received antibiotics.

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