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

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.
ClinicalTrials.gov Identifier: NCT00503490
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : January 19, 2018
Information provided by (Responsible Party):
Horizon Pharma USA, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: MP-376 (Levofloxacin solution for Inhalation) Drug: placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : June 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: 1
Inhaled Levofloxacin
Drug: MP-376 (Levofloxacin solution for Inhalation)
40, 80, 120mg RDD

Placebo Comparator: 2
Drug: placebo

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00503490

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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
Horizon Pharma USA, Inc.
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Responsible Party: Horizon Pharma USA, Inc.
ClinicalTrials.gov Identifier: NCT00503490    
Other Study ID Numbers: Mpex-203
First Posted: July 18, 2007    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
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