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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 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 322 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG MP-376

Trial Details

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

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT00739648

The ClinicalTrials.gov registry entry for NCT00739648 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 322 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

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

NCT00739648 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.