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Randomized Controlled Trial
. 2015 May;135(5):1171-8.e1.
doi: 10.1016/j.jaci.2014.10.001. Epub 2014 Nov 18.

Randomized trial to evaluate azithromycin's effects on serum and upper airway IL-8 levels and recurrent wheezing in infants with respiratory syncytial virus bronchiolitis

Avraham Beigelman  1 , Megan Isaacson-Schmid  2 , Geneline Sajol  3 , Jack Baty  4 , Oscar M Rodriguez  2 , Erin Leege  2 , Kevin Lyons  2 , Toni L Schweiger  3 , Jie Zheng  4 , Kenneth B Schechtman  4 , Mario Castro  3 , Leonard B Bacharier  2
Affiliations
Randomized Controlled Trial

Randomized trial to evaluate azithromycin's effects on serum and upper airway IL-8 levels and recurrent wheezing in infants with respiratory syncytial virus bronchiolitis

Avraham Beigelman et al. J Allergy Clin Immunol. 2015 May.

Abstract

Background: Respiratory syncytial virus (RSV) bronchiolitis in infancy is a major risk factor for recurrent wheezing and asthma. Because azithromycin attenuated neutrophilic airway inflammation in a murine viral bronchiolitis model, demonstration of similar effects in human subjects might provide a strategy for the prevention of postbronchiolitis recurrent wheezing.

Objectives: We sought to investigate whether azithromycin treatment during RSV bronchiolitis reduces serum and nasal lavage IL-8 levels and the occurrence of postbronchiolitis recurrent wheezing.

Method: We performed a randomized, double-masked, placebo-controlled proof-of-concept trial in 40 otherwise healthy infants hospitalized with RSV bronchiolitis who were treated with azithromycin or placebo for 14 days. IL-8 levels were measured in nasal lavage fluid and serum on randomization, day 8, and day 15 (nasal lavage only). The occurrence of wheezing episodes was assessed monthly over the ensuing 50 weeks.

Results: Compared with placebo, azithromycin treatment did not reduce serum IL-8 levels at day 8 (P = .6) but resulted in a greater decrease in nasal lavage fluid IL-8 levels by day 15 (P = .03). Twenty-two percent of azithromycin-treated participants experienced at least 3 wheezing episodes compared with 50% of participants in the placebo group (P = .07). Azithromycin treatment resulted in prolonged time to the third wheezing episode (P = .048) and in fewer days with respiratory symptoms over the subsequent year in comparison with placebo (36.7 vs 70.1 days, P = .01).

Conclusion: In this proof-of-concept study azithromycin treatment during RSV bronchiolitis reduced upper airway IL-8 levels, prolonged the time to the third wheezing episode, and reduced overall respiratory morbidity over the subsequent year.

Keywords: Azithromycin; IL-8; respiratory syncytial virus; wheezing.

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Figures

Figure 1
Figure 1
Participants flow of the APW-RSV trial APW-RSV: Azithromycin to Prevent Wheezing following RSV Bronchiolitis. aPatients were screened for eligibility if they were hospital in St. Louis children’s Hospital during the RSV season with lower respiratory tract symptoms, and had a positive nasopharyngeal swab result confirming infection with RSV. bSome patients were excluded based on more than one exclusion criteria. Details for those screened but not eligible were not collected. COne of the patients who was lost to follow-up had 11 (out of 12) months of follow-up, and contributed all biological samples for cytokine measurements.
Figure 2
Figure 2
APW-RSV Study design Hx/PE: History/Physical exam; Sx: Symptom
Figure 3
Figure 3
Mean serum IL-8 levels (on a logarithmic scale) between randomization to day 8. p=0.62 for the change in serum IL-8 concentration measured between randomization and day 8 compared between the treatment groups
Figure 4
Figure 4
Mean nasal lavage IL-8 levels (on a logarithmic scale) over the treatment period. * p=0.03 for the change in nasal lavage IL-8 concentration measured between randomization and day 15 compared between the treatment groups.
Figure 5
Figure 5
Probability of not having at least three episodes of wheezing
See this image and copyright information in PMC

Comment in

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