MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis

This study has been completed.
Sponsor:
Collaborator:
Aptalis Pharma
Information provided by (Responsible Party):
Mpex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01180634
First received: August 10, 2010
Last updated: July 11, 2013
Last verified: July 2013
  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. Decreased efficacy, intolerance and high treatment burden with currently available therapies indicate a need for additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active against CF pathogens including those with high minimum inhibitory concentration (MIC) levels to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered rapidly and efficiently using a customized PARI investigational configuration of the eFlow® nebulizer system.


Condition Intervention Phase
Cystic Fibrosis
Drug: MP-376 (Levofloxacin solution for Inhalation)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) In Stable Cystic Fibrosis Patients

Resource links provided by NLM:


Further study details as provided by Mpex Pharmaceuticals:

Primary Outcome Measures:
  • Time to an exacerbation [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to administration of other anti-pseudomonal antimicrobials [ Time Frame: 56 days ] [ Designated as safety issue: No ]
  • Evaluate changes in FEV1, FEF 25-75 and FVC from baseline to end of treatment [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Changes in bacterial load and susceptibility patterns of isolated organisms from baseline to end of treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Changes in respiratory domain of CFQ-R from baseline to end of treatment baseline to end of treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Evaluate the safety of MP-376 administered over 28 days, compared to placebo [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Enrollment: 330
Study Start Date: November 2010
Study Completion Date: September 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Inhaled MP-376 (Aeroquin)
Drug: MP-376 (Levofloxacin solution for Inhalation)
240 mg of MP-376 administered BID for 28 days
Placebo Comparator: 2
Placebo
Drug: Placebo
same volume and frequency as study drug

Detailed Description:

This trial will be a double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin administered as MP-376 given for 28 days by the aerosol route to CF patients.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (selected):

  • >/= 12 years of age
  • Confirmed Diagnosis of Cystic Fibrosis
  • Positive sputum culture for P. aeruginosa at screening and within the past 12 months
  • Patients are able to elicit an FEV1 >/= 25% but </= 85% of predicted value at screening
  • Have received at least 3 courses of inhaled antimicrobials over the preceding 12 months
  • Clinically stable with no changes in health status within the last 28 days
  • Able to reproducibly produce sputum and perform spirometry

Exclusion Criteria (selected):

  • Use of any nebulized or systemic antibiotics within 28 days prior to baseline
  • History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
  • Evidence of respiratory infections within 14 days prior to dosing
  • CrCl < 20ml/min or < 20ml/min/1.73 m2 at Screening
  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: NCT01180634

  Hide Study Locations
Locations
United States, Alabama
Mobile, Alabama, United States, 36608
United States, Alaska
Anchorage, Alaska, United States, 99508
United States, Arizona
Phoenix, Arizona, United States, 85016
Tucson, Arizona, United States, 85724
United States, California
La Jolla, California, United States, 92037
Long Beach, California, United States, 90806
Los Angeles, California, United States, 90033
Childrens Hospital
Los Angeles, California, United States, 90027
Oakland, California, United States, 94611
Orange, California, United States, 92868
Palo Alto, California, United States, 94304
Sacramento, California, United States, 95817
San Diego, California, United States, 92103
San Francisco, California, United States, 94143
San Francisco, California, United States, 94115
United States, Colorado
Aurora, Colorado, United States, 80045
Denver, Colorado, United States, 80206
United States, Connecticut
Hartford, Connecticut, United States, 06106
United States, Delaware
Wilmington, Delaware, United States, 19803
United States, Florida
Jacksonville, Florida, United States, 32207
Miami, Florida, United States, 33136
Orlando, Florida, United States, 32801
St. Petersburg, Florida, United States, 33701
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Idaho
Boise, Idaho, United States, 83712
United States, Illinois
Chicago, Illinois, United States, 60614
Chicago, Illinois, United States, 60637
Glenview, Illinois, United States, 60025
Milwaukee, Illinois, United States, 53201
Niles, Illinois, United States, 60714
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Lexington, Kentucky, United States, 40536
Louisville, Kentucky, United States, 40202
United States, Louisiana
New Orleans, Louisiana, United States, 70011
United States, Maine
Portland, Maine, United States, 04102
United States, Massachusetts
Boston, Massachusetts, United States, 02115
Boston, Massachusetts, United States, 02114
Worcester, Massachusetts, United States, 01655
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Detroit, Michigan, United States, 48201
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
Jackson, Mississippi, United States, 39216
United States, Missouri
Columbia, Missouri, United States, 65212
Kansas City, Missouri, United States, 64108
St. Louis, Missouri, United States, 63110
St. Louis, Missouri, United States, 63104
United States, Nebraska
Omaha, Nebraska, United States, 68198
United States, Nevada
Las Vegas, Nevada, United States, 89107
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
Manchester, New Hampshire, United States, 03104
United States, New Jersey
Livingston, New Jersey, United States, 07039
Long Branch, New Jersey, United States, 07440
Morristown, New Jersey, United States, 07962
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Albany, New York, United States, 12208
New York, New York, United States, 10011
New York, New York, United States, 10003
New York, New York, United States, 10032
Syracuse, New York, United States, 13210
Valhalla, New York, United States, 10595
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Akron, Ohio, United States, 44308
Cincinnati, Ohio, United States, 45229
Columbus, Ohio, United States, 43205
Dayton, Ohio, United States, 45404
Toledo, Ohio, United States, 43606
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Philadelphia, Pennsylvania, United States, 19102
Philadelphia, Pennsylvania, United States, 19104
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Charleston, South Carolina, United States, 29425
Columbia, South Carolina, United States, 29203
United States, South Dakota
Sioux Falls, South Dakota, United States, 57117
United States, Tennessee
Memphis, Tennessee, United States, 38105
Nashville, Tennessee, United States, 37232
United States, Texas
Austin, Texas, United States, 78723
Dallas, Texas, United States, 75390
Fort Worth, Texas, United States, 76104
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78212
Tyler, Texas, United States, 75708
United States, Utah
Salt Lake City, Utah, United States, 84132
United States, Vermont
Colchester, Vermont, United States, 05446
United States, Virginia
Charlottesville, Virginia, United States, 22908
Norfolk, Virginia, United States, 23507
Portsmouth, Virginia, United States, 23708
Richmond, Virginia, United States, 23298
United States, Washington
Seattle, Washington, United States, 98105
Seattle, Washington, United States, 98195
United States, West Virginia
Morgantown, West Virginia, United States, 26506
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia
Westmead Chilren's Hospital
Westmead, New South Wales, Australia
Australia, Queensland
Brisbane, Queensland, Australia
Mater Miscericordiae Hospital
Brisbane, Queensland, Australia
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Australia, Victoria
Royal Children's Hospital
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Australia
Monash Medical Center
Melbourne, Australia
John Hunter Hospital
New South Wales, Australia
Canada, Ontario
Hamilton, Ontario, Canada, L8N3Z5
Kingston, Ontario, Canada, K7L5G2
Ottawa, Ontario, Canada, K1H8L6
Israel
Rambam Medical Center
Haifa, Israel, 31096
Hadassah Medical Center Mount Scopus
Jerusalem, Israel, 91240
Schneider Childrens Medical Center of Israel
Petah Tikva, Israel, 49202
Sheba Medical Center
Ramat-Gan, Israel, 52620
New Zealand
Auckland Hospital
Auckland, New Zealand
Sponsors and Collaborators
Mpex Pharmaceuticals
Aptalis Pharma
Investigators
Principal Investigator: Patrick Flume, M.D. MUSC
  More Information

No publications provided

Responsible Party: Mpex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01180634     History of Changes
Other Study ID Numbers: Mpex-207
Study First Received: August 10, 2010
Last Updated: July 11, 2013
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
Pharmaceutical Solutions
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 October 20, 2014