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NCT00739648 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Amgen.

Completed
Registry status
Phase 2
Development phase
322
Enrollment target

NCT00739648: Completed Phase 2 study, sponsored by Amgen.

NCT00739648 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 322 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (142% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00739648, a Phase 2 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 2
Development phase
322 participants
Enrollment target

Study 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.

Primary Outcome

The number of acute exacerbations per patient-year of study participation, where an acute exacerbation was defined as a deterioration in respiratory symptoms that required treatment with antibiotics, corticosteroids, hospitalization or a combination of those treatments.

Interventions

  • DRUG Placebo
  • DRUG MP-376

Trial Details

FieldValue
Enrollment Target 322 participants
Start Date 2008-10
Est. Completion 2010-04
Phase Phase 2
Amgen

558 total trials

What the finished NCT00739648 record still lists

NCT00739648 is an interventional study that assigns participants to a tested intervention. The registered 322 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (142% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00739648 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00739648 about?

NCT00739648 is a clinical study titled "A Phase 2 Study of MP-376 to Prevent Acute Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients". 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 ch...

What is the current status of trial NCT00739648?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 322 participants. The study started on 2008-10. Estimated completion is 2010-04.

What interventions are being tested in trial NCT00739648?

The interventions under investigation include: Placebo (DRUG), MP-376 (DRUG).

Who is sponsoring clinical trial NCT00739648?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00739648's enrollment target sits among peer trials

322 150th of 2000 higher than 1,850 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00739648, the US trial registry maintained by the National Library of Medicine. NCT00739648 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.