Abstract
Previous aztreonam for inhalation solution (AZLI) studies included patients with cystic fibrosis,
Pseudomonas aeruginosa (
PA) airway infection, and forced expiratory volume in 1
s (FEV
1) 25% to 75% predicted. This double-blind, multicenter, randomized, placebo-controlled trial enrolled patients (≥
6
years) with FEV
1
>
75% predicted.
AZLI 75
mg (n
=
76) or placebo (n
=
81) was administered 3-times daily for 28
days with a 14-day follow-up.
Day 28 treatment effects were 1.8
points 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.
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. ClinicalTrials.gov identifier: NCT00712166.
