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

被引：70

作者：

Wainwright, C. E. ^{[1
]}

Quittner, A. L. ^{[2
]}

Geller, D. E. ^{[3
]}

Nakamura, C. ^{[4
]}

Wooldridge, J. L. ^{[5
]}

Gibson, R. L. ^{[6
]}

Lewis, S. ^{[7
]}

Montgomery, A. B. ^{[7
]}

机构：

[1] Royal Childrens Hosp, Queensland Childrens Resp Ctr, Herston, Qld 4029, Australia

[2] Univ Miami, Coral Gables, FL 33146 USA

[3] Nemours Childrens Clin, Orlando, FL 32803 USA

[4] Childrens Lung Specialists, Las Vegas, NV USA

[5] Cincinnati Childrens Hosp, Med Ctr, Cincinnati, OH 45229 USA

[6] Reg Med Ctr, Seattle, WA 98105 USA

[7] Gilead Sci Inc, Seattle, WA 98102 USA

来源：

JOURNAL OF CYSTIC FIBROSIS | 2011年 / 10卷 / 04期

关键词：

Aztreonam; Cystic fibrosis; Respiratory symptoms; Inhaled antibiotics; Pseudomonas; PSEUDOMONAS-AERUGINOSA; AIRWAY PSEUDOMONAS; LYSINE; EFFICACY; DECLINE; DISEASE; SAFETY; HEALTH; VOLUME; CF;

D O I：

10.1016/j.jcf.2011.02.007

中图分类号：

R56 [呼吸系及胸部疾病];

学科分类号：

摘要：

Background: 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. Methods: AZLI 75 mg (n=76) or placebo (n=81) was administered 3-times daily for 28 days with a 14-day follow-up. Results: 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. AZL1 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. ClinicalTrials.gov identifier: NCT00712166. (C) 2011 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

引用

页码：234 / 242

页数：9

共 50 条

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