Study design (if review, criteria of inclusion for studies)
Double-blind, placebo-controlled trial
Participants
Individuals with cystic fibrosis (CF) and chronic Burkholderia spp. infection.
Interventions
24-week of continuous AZLI/placebo treatment
Outcome measures
FEV1% predicted, number of respiratory exacerbations requiring systemic/inhaled antibiotics, or hospitalizations.
Main 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.
Authors' conclusions
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.