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Long term azithromycin in children with cystic fibrosis: a randomised, placebo-controlled crossover trial

A Equi1, I M Balfour-Lynn, A Bush

  • 1Department of Paediatric Respiratory Medicine, Royal Brompton Hospital, London, UK.

Lancet (London, England)
|October 18, 2002
PubMed

Insights

Azithromycin showed a modest benefit in lung function for children with cystic fibrosis. This antibiotic may reduce the need for oral antibiotic courses in CF patients.

Area of Science:

  • Pulmonology
  • Pediatrics
  • Pharmacology

Background:

  • Azithromycin, a macrolide antibiotic, possesses anti-inflammatory properties.
  • Pilot studies suggested potential clinical benefits of azithromycin in cystic fibrosis (CF).

Purpose of the Study:

  • To formally evaluate the efficacy of azithromycin in children with cystic fibrosis.

Main Methods:

  • A 15-month randomized, double-blind, placebo-controlled crossover trial involving 41 children with CF (aged 8-18).
  • Patients received azithromycin or placebo for 6 months, followed by a 2-month washout and then crossed over.
  • Primary outcome was the relative difference in forced expiratory volume in 1 second (FEV1); secondary outcomes included inflammatory markers, exercise testing, and antibiotic use.

Main Results:

  • A median relative difference in FEV1 of 5.4% favoring azithromycin (p=0.059).
  • Significantly fewer oral antibiotic courses were needed in the azithromycin group (p=0.005).
  • No significant changes in inflammatory markers, exercise tolerance, or subjective well-being were observed.

Conclusions:

  • A 4-6 month trial of azithromycin is warranted for children with CF unresponsive to conventional therapies.
  • The precise mechanism of azithromycin's benefit in CF remains undetermined.
Abstract

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