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Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by:
Mpex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00503490
First received: July 16, 2007
Last updated: April 22, 2008
Last verified: April 2008
  Purpose

Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms and reduce the emergence of resistant bacteria.


Condition Intervention Phase
Cystic Fibrosis
Drug: MP-376 (Levofloxacin solution for Inhalation)
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase I, Single and Multi-Dose, Placebo Controlled, Randomized, Dose-Escalation Study to Evaluate the Safety, Tolerability and PK Profile of MP-376 Using the PARI eFlow Nebulizer for 14 Days to CF Patients

Resource links provided by NLM:


Further study details as provided by Mpex Pharmaceuticals:

Primary Outcome Measures:
  • Safety and tolerability of MP-376 administered twice a day for 14 days [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Evaluate changes in the microbiology of CF sputum after 14 days of treatment with MP-376 [ Time Frame: 14 days ]
  • PK Profile of single-dose vs multi-dose of MP-376 [ Time Frame: 14 days ]
  • Evaluate changes in FEV1 and FVC over 14 days of Treatment [ Time Frame: 14 days ]

Enrollment: 40
Study Start Date: June 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Inhaled Levofloxacin
Drug: MP-376 (Levofloxacin solution for Inhalation)
40, 80, 120mg RDD
Placebo Comparator: 2
Placebo
Drug: placebo
BID
Other Name: placebo

Detailed Description:

This trial will be a single-blind, placebo-controlled, dose escalating between cohorts, single and multi-dose, multi-center study to evaluate the safety, tolerability and pharmacokinetic profile of levofloxacin administered as MP-376 once, then twice daily for 14 days by the aerosol route to CF patients.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 16 years of age
  • Confirmed Diagnosis of Cystic Fibrosis
  • Positive sputum culture for P. aeruginosa within the past 6 months
  • Patients are able to elicit an FEV1 >/= 40% of predicted value at screening
  • Clinically stable with no evidence of acute respiratory or lower respiratory infections within 28 days prior to dosing
  • Able to reproducibly perform spirometry measurements and be able to repeatedly produce sputum over several hours

Exclusion Criteria:

  • Use of any nebulized or systemic antibiotics within 4 weeks of starting study
  • History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
  • Uncontrolled diabetes or abnormal renal function
  • Tobacco use (smoking) in the last 30 days
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503490

Locations
United States, California
La Jolla, California, United States, 92037
Los Angeles, California, United States, 90033
Palo Alto, California, United States, 94303
United States, Florida
Orlando, Florida, United States, 32801
United States, Michigan
Kalamazoo, Michigan, United States, 49007
United States, Nebraska
Omaha, Nebraska, United States, 68154
United States, New York
Albany, New York, United States, 12208
New Hyde Park, New York, United States, 11040
United States, Ohio
Columbus, Ohio, United States, 43205
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, South Carolina
Charleston, South Carolina, United States, 29203
Charleston, South Carolina, United States, 29425
United States, Texas
San Antonio, Texas, United States, 78212
United States, Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Mpex Pharmaceuticals
Investigators
Study Director: Michael N Dudley, Pharm.D Sponsor GmbH
  More Information

No publications provided

Responsible Party: Elizabeth E. Morgan, Mpex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00503490     History of Changes
Other Study ID Numbers: Mpex-203
Study First Received: July 16, 2007
Last Updated: April 22, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Levofloxacin
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014