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.
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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: Chris Stockmann; Jessica K Roberts; Venkata K Yellepeddi; Catherine M T Sherwin Journal: Clin Pharmacokinet Date: 2015-05 Impact factor: 6.447
Authors: Kathryn McLean; Duankun Lee; Elizabeth A Holmes; Kelsi Penewit; Adam Waalkes; Mingxin Ren; Samuel A Lee; Joseph Gasper; Colin Manoil; Stephen J Salipante Journal: Antimicrob Agents Chemother Date: 2019-08-23 Impact factor: 5.191
Authors: Christopher H Goss; Yukihiro Kaneko; Lisa Khuu; Gail D Anderson; Sumedha Ravishankar; Moira L Aitken; Noah Lechtzin; Guolin Zhou; Daniel M Czyz; Kathryn McLean; Oyebode Olakanmi; Howard A Shuman; Mary Teresi; Ellen Wilhelm; Ellen Caldwell; Stephen J Salipante; Douglas B Hornick; Richard J Siehnel; Lev Becker; Bradley E Britigan; Pradeep K Singh Journal: Sci Transl Med Date: 2018-09-26 Impact factor: 17.956