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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00752414
First Posted: September 15, 2008
Last Update Posted: December 23, 2008
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.
Information provided by:
Forest Laboratories
  Purpose

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.


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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

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

Estimated Enrollment: 20
Study Start Date: July 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MP-376 Inhalation Solution
Drug: MP-376 (Levofloxacin solution for Inhalation)
Daily for 5 days
Placebo Comparator: 2
Placebo
Drug: Placebo
same frequency as MP-376

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.
  Eligibility

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.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00752414


Locations
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
Forest Laboratories
Investigators
Principal Investigator: Sanjay Sethi, M.D. University at Buffalo
  More Information

Responsible Party: Elizabeth E. Morgan, Mpex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00752414     History of Changes
Other Study ID Numbers: Mpex-301
First Submitted: September 11, 2008
First Posted: September 15, 2008
Last Update Posted: December 23, 2008
Last Verified: December 2008

Keywords provided by Forest Laboratories:
COPD
Patients

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Pharmaceutical Solutions
Levofloxacin
Ofloxacin
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