Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Impairment, and P. Aeruginosa

J Cyst Fibros. 2011 Jul;10(4):234-42. doi: 10.1016/j.jcf.2011.02.007. Epub 2011 Mar 26.

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 (FEV(1)) 25% to 75% predicted. This double-blind, multicenter, randomized, placebo-controlled trial enrolled patients (≥6 years) with FEV(1)>75% predicted.

Methods: AZLI 75 mg (n=76) or placebo (n=81) was administered 3-times daily for 28days 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 log(10) sputum PA colony-forming units (p=0.016; favoring AZLI), and 2.7% for relative FEV(1)% predicted (p=0.021; favoring AZLI). Treatment effects favoring AZLI were larger for patients with baseline FEV(1) <90% predicted compared to ≥90% predicted. AZLI was well-tolerated.

Conclusions: Effects on respiratory symptoms were modest; however, FEV(1) improvements and bacterial density reductions support a possible role for AZLI in these relatively healthy patients.

Trial registration: ClinicalTrials.gov NCT00712166.

Publication types

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

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / adverse effects
  • Aztreonam / administration & dosage*
  • Aztreonam / adverse effects
  • Child
  • Cystic Fibrosis / microbiology*
  • Female
  • Forced Expiratory Volume / drug effects
  • Humans
  • Male
  • Placebos
  • Pseudomonas Infections / drug therapy*
  • Pseudomonas aeruginosa / drug effects*
  • Severity of Illness Index
  • Therapeutics
  • Young Adult

Substances

  • Anti-Bacterial Agents
  • Placebos
  • Aztreonam

Associated data

  • ClinicalTrials.gov/NCT00712166