Original Article
Inhaled aztreonam for chronic Burkholderia infection in cystic fibrosis: A placebo-controlled trial,☆☆,

https://doi.org/10.1016/j.jcf.2013.08.011Get rights and content
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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

Cited by (0)

Study results were reported in part at the North American Cystic Fibrosis Conference, November 2011, Anaheim, CA, USA; the International Burkholderia cepacia Working Group meeting, April 2012, Montreal, Québec, Canada; and the European Cystic Fibrosis Conference, 2012, Dublin, Ireland.

☆☆

Clinical trials.gov: NCT01059565.

Other members are listed at the end of the manuscript.