Mode
Text Size
Log in / Sign up
Phase 2 N=322 Randomized Quadruple-blind Treatment

A Phase 2 Study of MP-376 to Prevent Acute Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients

Chronic Obstructive Pulmonary Disease

Enrolled (actual)
322
Serious AEs
32.3%
Results posted
Mar 2012
Primary outcome: Primary: Exacerbation Rate — 1.20; 1.31 exacerbation per patient year — p=0.7282

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
MP-376 (Drug); Placebo (Drug)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Amgen
Primary completion
Jan 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Exacerbation Rate
1.20; 1.31 0.7282
SECONDARY
Duration of Acute Exacerbation
12.9; 11.6
SECONDARY
Percent Change in Forced Vital Capacity (FVC)
14.46; -0.77 0.9768
SECONDARY
Percent Change in Forced Expiratory Volume in 1 Second (FEV1)
14.76; 2.42 0.9464

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 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.

Eligibility Criteria

Inclusion Criteria (selected):

  • > 40 years of age
  • History of COPD
  • Forced expiratory volume in 1 second (FEV1) /= 5 x upper limit of normal (ULN) or total bilirubin >/= 3 x ULN at Screening
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00739648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search