A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients.
J Cyst Fibros
; 14(4): 507-14, 2015 Jul.
Article
em En
| MEDLINE
| ID: mdl-25592656
ABSTRACT
BACKGROUND:
Inhaled antibiotics are standard of care for persons with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa airway infection. APT-1026 (levofloxacin inhalation solution, LIS) is fluoroquinolone in development. We compared the safety and efficacy of LIS to tobramycin inhalation solution (TIS) in persons ≥12 years old with CF and chronic P. aeruginosa infection.METHODS:
This multinational, randomized (21), non-inferiority study compared LIS and TIS over three 28-day on/off cycles. Day 28 FEV(1) % predicted relative change was the primary endpoint. Time to exacerbation and patient-reported quality of life were among secondary endpoints.RESULTS:
Baseline demographics for 282 subjects were comparable. Non-inferiority was demonstrated (1.86% predicted mean FEV(1) difference [95% CI -0.66 to 4.39%]). LIS was well-tolerated, with dysgeusia (taste distortion) as the most frequent adverse event.CONCLUSIONS:
LIS is a safe and effective therapy for the management of CF patients with chronic P. aeruginosa infection.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Pseudomonas aeruginosa
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Infecções por Pseudomonas
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Tobramicina
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Fibrose Cística
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Levofloxacino
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Antibacterianos
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article