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

Study Overview
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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.

Official Title
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Phase 1b, Randomized, Single-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MP-376 Inhalation Solution Administered for 5 Days to Chronic Bronchitis Patients

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: MP-376 (Levofloxacin solution for Inhalation)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (selected): >/= 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 (selected): 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MP-376 Inhalation Solution | Drug: MP-376 (Levofloxacin solution for Inhalation)<br>* Daily for 5 days<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* same frequency as MP-376<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety, tolerability and PK of two dosage regimens of MP-376 |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Patients