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MP-376

A Phase 1b Study to Evaluate the Safety and PK of MP-376 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Ensayo de AMGEN INC en EPOC.

Más ensayos de: EPOC.

Fase

Fase 1

Estado

Completado

Participantes

21

previstos

Centros

5

Fin del objetivo primario

oct 2008

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, simple ciego. Comenzó en jul 2008.

Qué mide

Evaluate the safety, tolerability and PK of two dosage regimens of MP-376 (del registro, en inglés) (2 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPatients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent acute exacerbations (AECB) which are associated with enormous healthcare expenditures and significant morbidity, specifically an increased risk of death, a decline in pulmonary function and a significant change in quality of life. Bacteria appear to have an important role in acute exacerbations in chronic bronchitis and COPD. Studies of acute exacerbations in COPD have shown a reduction in bacterial load with prolonged exacerbation-free interval. In addition, recent studies indicate that acquisition of a new strain of H. influenzae, M. catarrhalis, S. pneumoniae or P. aeruginosa are responsible for many of these exacerbations. Chronic inflammation and bacterial infection predispose many patients to frequent and recurrent acute exacerbations. Mpex, (the sponsor on record at time of the study's initial registration) believes that intermittent administration of inhaled MP-376 in high risk patients will decrease the incidence of acute exacerbations by both by lowering the organism burden, and resultant inflammation, as well as pre-emptive eradication of any newly acquired bacterial strains.

Más ensayos de AMGN

Todos los de AMGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00752414), actualizada en dic 2024.