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NCT00752414 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b Study to Evaluate the Safety and PK of MP-376 in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT00752414 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 21 participants.
The verdict
NCT00752414, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 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, (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.
Interventions
- DRUG Placebo
- DRUG MP-376 (Levofloxacin solution for Inhalation)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2008-07 |
| Est. Completion | 2008-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00752414
The ClinicalTrials.gov registry entry for NCT00752414 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 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.
NCT00752414 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00752414 about?
NCT00752414 is a clinical study titled "A Phase 1b Study to Evaluate the Safety and PK of MP-376 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 NCT00752414?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2008-07. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00752414?
The interventions under investigation include: Placebo (DRUG), MP-376 (Levofloxacin solution for Inhalation) (DRUG).
Who is sponsoring clinical trial NCT00752414?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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