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ARIKACE™

Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)

Ensayo de INSMED Inc en Fibrosis quistica.

Más ensayos de: Fibrosis quística.

Fase

Fase 1/2

Estado

Completado

Participantes

66

previstos

Centros

11

Fin del objetivo primario

feb 2008

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en feb 2007.

Qué mide

Clinically Significant Laboratory Abnormalities. (del registro, en inglés) (28 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroA major factor in the respiratory health of cystic fibrosis (CF) subjects is acquisition of chronic Pseudomonas aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18 years, 80% of CF subjects in the U.S. are infected. Liposomal Amikacin for Inhalation (Arikace™) is a sterile aqueous liposomal suspension consisting of amikacin sulfate encapsulated in liposomes. This formulation of amikacin maximizes the achievable dose and delivery to the lungs of subjects infected via a nebulizer. Because liposome particles are small enough to penetrate and diffuse through sputum into the bacterial biofilm, they deposit drug in close proximity to the bacterial colonies, thus improving the bioavailability of amikacin at the infection site. The clinically achievable doses of amikacin in the LAI formulation can effectively increase the half-life of the drug in the lungs, and decrease the potential for systemic toxicity. LAI offers several advantages over current therapies in treating CF subjects with chronic infection caused by P. aeruginosa.

Más ensayos de INSM

Todos los de INSM, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00777296), actualizada en jul 2020.