title: Inhaled aztreonam for chronic Burkholderia infection in cystic fibrosis: a placebo-controlled trial.
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.
authors.affiliation: Department of Medicine, University of Toronto, Keenan Research Centre of Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada. Electronic address: tullise@smh.ca.
authors.forename: D Elizabeth
authors.initials: DE
authors.lastname: Tullis
authors.affiliation: University of Washington, Seattle Children's Research Institute, 1900 Ninth Avenue C9S8, Seattle, WA 98101, USA.
authors.forename: Jane L
authors.initials: JL
authors.lastname: Burns
authors.affiliation: University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.
authors.forename: George Z
authors.initials: GZ
authors.lastname: Retsch-Bogart
authors.affiliation: Gilead Sciences, 333 Lakeside Dr., Foster City, CA 94404, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Bresnik
authors.affiliation: Gilead Sciences, 333 Lakeside Dr., Foster City, CA 94404, USA.
authors.forename: Noreen R
authors.initials: NR
authors.lastname: Henig
authors.affiliation: Gilead Sciences, 199 E. Blaine St., Seattle, WA 98102, USA.
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Lewis
authors.affiliation: Department of Pediatrics and Communicable Diseases, University of Michigan, Ann Arbor, MI 48109, USA.
authors.forename: John J
authors.initials: JJ
authors.lastname: Lipuma
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001398:Aztreonam / Q000008:administration & dosage*; D019121:Burkholderia Infections / Q000188:drug therapy*; D002648:Child; D002908:Chronic Disease; D003550:Cystic Fibrosis / Q000382:microbiology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010919:Placebos; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D010919:Placebos; D001398:Aztreonam
keywords: Antipseudomonal; Cepacia complex; Inhaled antibiotics; Pseudomonas aeruginosa; Respiratory exacerbations