Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: A comparative efficacy trial
- ASSAEL, BAROUKHMAURICE
- Tacjana Pressler
- Diana Bilton
- Michael Fayon
- Rainald Fischer
- Raphael Chiron
- Mario LaRosa
- Christiane Knoop
- Noel McElvaney
- Sandra A. Lewis
- Mark Bresnik
- A. Bruce Montgomery
- Christopher M. Oermann
DOIAbstract
BACKGROUND: Open-label, parallel-group, international trial comparing aztreonam for inhalation solution (AZLI) and tobramycin nebulizer solution (TNS) for cystic fibrosis patients with airway Pseudomonas aeruginosa. METHODS: 273 patients (≥6years); randomized to three 28-day courses (AZLI 75mg [three-times/day] or TNS 300mg [twice/day]); 28 off-days separated each course. RESULTS: 268 patients were treated (AZLI/TNS: 136/132). Mean baseline FEV(1) was 52% predicted. Mean relative changes after 1 course (AZLI: 8.35%; TNS: 0.55%; p<0.001) and mean actual changes across 3 courses (AZLI: 2.05%; TNS: -0.66%; p=0.002) indicated AZLI statistical superiority vs. TNS. AZLI-treated patients had fewer respiratory hospitalizations (p=0.044) and respira...
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