A phase 2 study of aztreonam lysine for inhalation to treat patients with cystic fibrosis and Pseudomonas aeruginosa infection

Background Aztreonam lysine for inhalation (AZLI) is being developed for treatment of CF patients with Pseudomonas aeruginosa airway infection. Methods This double‐blind, randomized, placebo‐controlled Phase 2 study evaluated the safety, tolerability and efficacy of 75 and 225 mg AZLI administered B...

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Bibliographic Details
Published in:Pediatric pulmonology 2008-01, Vol.43 (1), p.47-58
Main Authors: Retsch-Bogart, George Z., Burns, Jane L., Otto, Kelly L., Liou, Theodore G., McCoy, Karen, Oermann, Christopher, Gibson, Ronald L.
Format: Article
Language:English
Subjects:
Administration, Inhalation
Adolescent
Adult
Anti-Bacterial Agents - administration & dosage
Anti-Bacterial Agents - therapeutic use
Aztreonam - administration & dosage
Aztreonam - therapeutic use
aztreonam lysine
Biological and medical sciences
cystic fibrosis
Cystic Fibrosis - complications
Cystic Fibrosis - drug therapy
Double-Blind Method
Errors of metabolism
Female
Forced Expiratory Flow Rates
General aspects
Human infectious diseases. Experimental studies and models
Humans
Infectious diseases
inhaled antibiotics
Male
Medical sciences
Metabolic diseases
Miscellaneous hereditary metabolic disorders
Nebulizers and Vaporizers
Pneumology
Pseudomonas aeruginosa
Pseudomonas Infections - complications
Pseudomonas Infections - drug therapy
Time Factors
Treatment Outcome
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Summary:Background Aztreonam lysine for inhalation (AZLI) is being developed for treatment of CF patients with Pseudomonas aeruginosa airway infection. Methods This double‐blind, randomized, placebo‐controlled Phase 2 study evaluated the safety, tolerability and efficacy of 75 and 225 mg AZLI administered BID for 14 days using the eFlow® Electronic Nebulizer (Pari Innovative Manufacturers, Inc., Midlothian, VA). Patients were 13 years and older with FEV1 ≥ 40% predicted, chronic P. aeruginosa infection, and had used no anti‐pseudomonal antibiotics for 56 days. Results Of 131 patients screened, 105 received AZLI or placebo. Mean age was 26 years and mean FEV1 percent predicted was 77% at baseline. There was a statistically significant reduction, compared to placebo, in P. aeruginosa CFU density in each AZLI group at Days 7 and 14 (P 
ISSN:8755-6863
1099-0496
DOI:10.1002/ppul.20736