title: Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa.
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.
authors: Queensland Children's Respiratory Centre, Royal Children's Hospital, Herston Rd. Herston, Queensland 4029, Australia. Claire_wainwright@health.qld.gov.au
authors: C E
authors: CE
authors: Wainwright
authors: A L
authors: AL
authors: Quittner
authors: D E
authors: DE
authors: Geller
authors: C
authors: C
authors: Nakamura
authors: J L
authors: JL
authors: Wooldridge
authors: R L
authors: RL
authors: Gibson
authors: S
authors: S
authors: Lewis
authors: A B
authors: AB
authors: Montgomery
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001398:Aztreonam / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D003550:Cystic Fibrosis / Q000382:microbiology*; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D010919:Placebos; D011552:Pseudomonas Infections / Q000188:drug therapy*; D011550:Pseudomonas aeruginosa / Q000187:drug effects*; D012720:Severity of Illness Index; D013812:Therapeutics; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D010919:Placebos; D001398:Aztreonam