Study design (if review, criteria of inclusion for studies)
double-blind, multicenter, randomized, placebo-controlled trial
Participants
CF patients (â¥6 years) with FEV(1)>75% predicted.
Interventions
AZLI 75 mg (n=76) or placebo (n=81) was administered 3-times daily for 28days with a 14-day follow-up.
Outcome measures
CFQ-R-Respiratory Symptoms Scale (primary endpoint); sputum PA colony-forming units, FEV(1)% predicted
Main 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 â¥90% predicted. AZLI was well-tolerated.
Authors' 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.
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