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A Phase 1b Study to Evaluate the Safety and PK of MP-376 in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT ID: NCT00752414

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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This study will be a Phase 1b, multi-center, randomized, single-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of MP-376 solution for inhalation given for 5 days to COPD patients.

Study acquired from Horizon in 2024.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

MP-376 Inhalation Solution

Group Type EXPERIMENTAL

MP-376 (Levofloxacin solution for Inhalation)

Intervention Type DRUG

Daily for 5 days

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

same frequency as MP-376

Interventions

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MP-376 (Levofloxacin solution for Inhalation)

Daily for 5 days

Intervention Type DRUG

Placebo

same frequency as MP-376

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \>/= 40 years of age
* History of COPD
* FEV1 \</= 65% of predicted and FEV1/FVC \</= 0.7 value at Screening
* Clinically stable with no changes in health status within the last 30 days
* Lifetime smoking history of at least 15 pack-years
* Willing and able to give informed consent

Exclusion Criteria

* Use of any systemic or inhaled antibiotics within 30 days prior to baseline
* History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
* CrCl \< 50/ml/min, AST, ALT or total bilirubin \>/= 3 x ULN at Screening
* Significant or unstable medical conditions
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Mobile, Alabama, United States

Site Status

Phoenix, Arizona, United States

Site Status

Omaha, Nebraska, United States

Site Status

Buffalo, New York, United States

Site Status

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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Mpex-301

Identifier Type: -

Identifier Source: org_study_id