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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00752414
Recruitment Status : Completed
First Posted : September 15, 2008
Last Update Posted : January 19, 2018
Information provided by (Responsible Party):
Horizon Pharma USA, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: MP-376 (Levofloxacin solution for Inhalation) Drug: Placebo Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : July 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: 1
MP-376 Inhalation Solution
Drug: MP-376 (Levofloxacin solution for Inhalation)
Daily for 5 days

Placebo Comparator: 2
Drug: Placebo
same frequency as MP-376

Primary Outcome Measures :
  1. Evaluate the safety, tolerability and PK of two dosage regimens of MP-376 [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00752414

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United States, Alabama
Mobile, Alabama, United States, 36608
United States, Arizona
Phoenix, Arizona, United States, 85006
United States, Nebraska
Omaha, Nebraska, United States, 68154
United States, New York
Buffalo, New York, United States, 14215
United States, Ohio
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Horizon Pharma USA, Inc.
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Principal Investigator: Sanjay Sethi, M.D. University at Buffalo

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Responsible Party: Horizon Pharma USA, Inc. Identifier: NCT00752414    
Other Study ID Numbers: Mpex-301
First Posted: September 15, 2008    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Keywords provided by Horizon Pharma USA, Inc.:
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Pharmaceutical Solutions
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors