A Phase 1b Study to Evaluate the Safety and PK of MP-376 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
Summary
Patients 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.