Phase 2
N=322
A Phase 2 Study of MP-376 to Prevent Acute Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT00739648 ↗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
| Outcome | Result | p-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
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.