CFDB - Cystic Fibrosis DataBase

primary studies published RCT

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

Study design (if review, criteria of inclusion for studies)

double-blind, multicenter, randomized, placebo-controlled trial

Participants

CF patients (≥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 ≥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.

Keywords: Adult; Aged; Anti-Bacterial Agents; Aztreonam; Bacterial Infections; Child; Infection; Inhalation OR nebulised; pharmacological_intervention; placebo; Pseudomonas aeruginosa; Pseudomonas; Respiratory Tract Diseases; Respiratory Tract Infections; Monobactams;