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Inhaled Aztreonam Lysine for Chronic Airway Pseudomonas aeruginosa in Cystic Fibrosis
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Inhaled Aztreonam Lysine for Chronic Airway Pseudomonas aeruginosa in Cystic Fibrosis
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Journal Article
Inhaled Aztreonam Lysine for Chronic Airway Pseudomonas aeruginosa in Cystic Fibrosis
2008
Overview
The effectiveness and safety of aztreonam lysine for inhalation (AZLI) in patients with cystic fibrosis (CF) on maintenance treatment for Pseudomonas aeruginosa (PA) airway infection was evaluated in this randomized, double-blind, placebo-controlled study.
To evaluate the safety and efficacy of inhaled aztreonam lysine in controlling PA infection in patients with CF.
After randomization and a 28-day course of tobramycin inhalation solution (TIS), patients (n = 211; > or =6 yr; > or =3 TIS courses within previous year; FEV(1) > or = 25% and < or =75% predicted values) were treated with 75 mg AZLI or placebo, twice or three times daily for 28 days, then monitored for 56 days. The primary efficacy endpoint was time to need for additional inhaled or intravenous antipseudomonal antibiotics. Secondary endpoints included changes in respiratory symptoms (CF Questionnaire-Revised [CFQ-R] Respiratory Scale), pulmonary function (FEV(1)), and sputum PA density. Adverse events and minimum inhibitory concentrations of aztreonam for PA were monitored.
AZLI treatment increased median time to need for additional antipseudomonal antibiotics for symptoms of pulmonary exacerbation by 21 days, compared with placebo (AZLI, 92 d; placebo, 71 d; P = 0.007). AZLI improved mean CFQ-R respiratory scores (5.01 points, P = 0.02), FEV(1) (6.3%, P = 0.001), and sputum PA density (-0.66 log(10) cfu/g, P = 0.006) compared with placebo; no AZLI dose-response was observed. Adverse events reported for AZLI and placebo were comparable and consistent with CF lung disease. Susceptibility of PA to aztreonam at baseline and end of therapy were similar.
AZLI was effective in patients with CF using frequent TIS therapy. AZLI delayed time to need for inhaled or intravenous antipseudomonal antibiotics, improved respiratory symptoms and pulmonary function, and was well tolerated. Clinical trial registered with www.clinicaltrials.gov (NCT 00104520).
Publisher
Am Thoracic Soc,American Lung Association,American Thoracic Society
Subject
/ Adult
/ Aged
/ Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
/ Anti-Bacterial Agents - administration & dosage
/ Anti-Bacterial Agents - adverse effects
/ Anti-Bacterial Agents - therapeutic use
/ Aztreonam - administration & dosage
/ Biological and medical sciences
/ Child
/ Cystic Fibrosis - complications
/ Cystic Fibrosis - microbiology
/ Emergency and intensive respiratory care
/ Female
/ Forced Expiratory Volume - drug effects
/ Humans
/ Male
/ Patients
/ Pseudomonas Infections - complications
/ Pseudomonas Infections - drug therapy
/ Respiratory Function Tests - methods
/ Respiratory Function Tests - statistics & numerical data
/ Serum Bactericidal Test - methods
/ Serum Bactericidal Test - statistics & numerical data
/ Steroids
