Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa

C. E. Wainwright, A. L. Quittner, D. E. Geller, C. Nakamura, J. L. Wooldridge, R. L. Gibson, S. Lewis, A. B. Montgomery

Research output: Contribution to journalArticle

59 Scopus citations

Abstract

Background: Previous aztreonam for inhalation solution (AZLI) studies included patients with cystic fibrosis, Pseudomonas aeruginosa (PA) airway infection, and forced expiratory volume in 1s (FEV1) 25% to 75% predicted. This double-blind, multicenter, randomized, placebo-controlled trial enrolled patients (≥6years) with FEV1>75% predicted. Methods: AZLI 75. mg (n = 76) or placebo (n = 81) was administered 3-times daily for 28. days with a 14-day follow-up. Results: Day 28 treatment effects were 1.8points for CFQ-R-Respiratory Symptoms Scale (95%CI: -2.8, 6.4; p=0.443; primary endpoint); -1.2 for log10 sputum PA colony-forming units (p=0.016; favoring AZLI), and 2.7% for relative FEV1% predicted (p=0.021; favoring AZLI). Treatment effects favoring AZLI were larger for patients with baseline FEV1 <90% predicted compared to ≥90% predicted. AZLI was well-tolerated. Conclusions: Effects on respiratory symptoms were modest; however, FEV1 improvements and bacterial density reductions support a possible role for AZLI in these relatively healthy patients. ClinicalTrials.gov identifier: NCT00712166.

Original languageEnglish (US)
Pages (from-to)234-242
Number of pages9
JournalJournal of Cystic Fibrosis
Volume10
Issue number4
DOIs
StatePublished - Jul 1 2011

Keywords

  • Aztreonam
  • Cystic fibrosis
  • Inhaled antibiotics
  • Pseudomonas
  • Respiratory symptoms

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Pediatrics, Perinatology, and Child Health

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    Wainwright, C. E., Quittner, A. L., Geller, D. E., Nakamura, C., Wooldridge, J. L., Gibson, R. L., Lewis, S., & Montgomery, A. B. (2011). Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa. Journal of Cystic Fibrosis, 10(4), 234-242. https://doi.org/10.1016/j.jcf.2011.02.007