Inhaled aztreonam for chronic Burkholderia infection in cystic fibrosis: a placebo-controlled trial

J Cyst Fibros. 2014 May;13(3):296-305. doi: 10.1016/j.jcf.2013.08.011. Epub 2013 Oct 28.

Abstract

Background: Individuals with Burkholderia spp. infection have historically been excluded from efficacy trials of inhaled antibiotics, including aztreonam for inhalation solution (AZLI).

Methods: A double-blind, placebo-controlled, 24-week trial of continuous AZLI/placebo treatment was undertaken in individuals with cystic fibrosis (CF) and chronic Burkholderia spp. infection. All subjects also received usual medical care (determined by their physicians). Additional antibiotic use was not restricted.

Results: Baseline FEV1% predicted values ranged from 15.8% to 114.6%. No significant treatment differences (AZLI vs. placebo) were observed at week 24 for any endpoints, including FEV1% predicted, number of respiratory exacerbations requiring systemic/inhaled antibiotics, or hospitalizations. Continuous AZLI administration was well tolerated. Burkholderia spp. susceptibility to antibiotics commonly used in CF therapy showed little change.

Conclusions: 24-weeks of continuous AZLI treatment did not significantly improve lung function in CF subjects with chronic Burkholderia spp. infection. Non-study antibiotic use may have confounded any potential AZLI effects.

Keywords: Antipseudomonal; Cepacia complex; Inhaled antibiotics; Pseudomonas aeruginosa; Respiratory exacerbations.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adult
  • Anti-Bacterial Agents / administration & dosage*
  • Aztreonam / administration & dosage*
  • Burkholderia Infections / drug therapy*
  • Child
  • Chronic Disease
  • Cystic Fibrosis / microbiology*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Placebos
  • Treatment Outcome
  • Young Adult

Substances

  • Anti-Bacterial Agents
  • Placebos
  • Aztreonam