Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients

This study has been completed.
Sponsor:
Collaborator:
Aptalis Pharma
Information provided by (Responsible Party):
Mpex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01270347
First received: January 3, 2011
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. 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.


Condition Intervention Phase
Cystic Fibrosis
Drug: MP-376 (Levofloxacin Solution for Inhalation)
Drug: TIS (Tobramycin Inhalation Solution)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable CF Patients

Resource links provided by NLM:


Further study details as provided by Mpex Pharmaceuticals:

Primary Outcome Measures:
  • Safety [ Time Frame: 168 and 336 days ] [ Designated as safety issue: Yes ]

    Assessment of adverse events and safety from Baseline through Final Visit

    Extension portion of Study: Descriptive statistics for all patients receiving at least one dose of MP-376 in the extension phase of the study will be summarized for the safety, microbiology, and disease-related endpoints. No formal hypothesis tests are planned.


  • Efficacy [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    Percent change in percent predicted FEV1 from Baseline to Day 28


Secondary Outcome Measures:
  • Changes in respiratory and other domains of CFQ-R from Baseline to Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Evaluate changes in FEV1 and FVC from Baseline to Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Changes in bacterial load and susceptability patterns of isolated organisms from Baseline to Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 267
Study Start Date: January 2011
Study Completion Date: June 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aeroquin
Aeroquin, Inhaled Levofloxacin (MP-376)
Drug: MP-376 (Levofloxacin Solution for Inhalation)
MP-376 (Aeroquin, Levofloxacin solution for Inhalation) 240 mg administered BID for 28-days treatment followed by 28 days off treatment
Other Name: (Aeroquin, Levofloxacin solution for Inhalation)
Active Comparator: TIS
Tobramycin Inhalation solution (TIS) [TOBI® Novartis Pharmaceuticals]
Drug: TIS (Tobramycin Inhalation Solution)
Tobramycin Inhalation Solution administered BID over 3 consecutive cycles of 28-days treatment followed by 28 days off treatment
Other Name: TOBI

Detailed Description:

This study will assess the comparative safety of MP-376 (Aeroquin) and Tobramycin Inhalation solution (TIS) [TOBI® Novartis Pharmaceuticals] over three consecutive cycles of 28-days treatment followed by 28-days off in stable CF patients with chronic P. aeruginosa lung infection. Efficacy data for MP-376 and TIS at the end of the first 28-day treatment period will also be compared, as well as explored over multiple treatment cycles.

Study patients participating in Mpex 209 will be given the option to participate in a six-month open label extension phase of the Mpex 209 protocol. The open label extension will allow enrolled patients to receive three additional courses of MP-376 (levofloxacin inhalation solution, Aeroquin™).

  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 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 tobramycin 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 inhaled or systemic aminoglycosides including tobramycin or any excipients
  • Evidence of acute upper within 10 days or lower respiratory infections within 28 days prior to dosing
  • CrCl < 20 at Screening
  • History of lung transplantation

Extension Portion of the Study: Patients enrolled in Mpex 209 are permitted to participate in the open label extension as long as they complete Visit 7 (Day 168), provide informed consent for participation in the open label extension of in the study and are clinically stable, as assessed by the Investigator.

  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: NCT01270347

  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, Arkansas
Little Rock, Arkansas, United States, 72202
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 Diego, California, United States, 92123
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
New Haven, Connecticut, United States, 65020
United States, Delaware
Wilmington, Delaware, United States, 19803
United States, Florida
Gainesville, Florida, United States, 32610
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
Niles, Illinois, United States, 60714
Peoria, Illinois, United States, 61637
United States, Indiana
Indianapolis, Indiana, United States, 43202
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, Maine
Portland, Maine, United States, 04102
United States, Maryland
Baltimore, Maryland, United States, 21287
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
United States, Nebraska
Omaha, Nebraska, United States, 68105
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
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
Albany Medical College #2
Albany, New York, United States, 12208
New Hyde Park, New York, United States, 11042
New York, New York, United States, 10032
New York, New York, United States, 10003
Syracuse, New York, United States, 13210
Valhalla, New York, United States, 10595
United States, North Carolina
Durham, North Carolina, United States, 27710
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 CF Center
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
United States, West Virginia
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53201
Milwaukee, Wisconsin, United States, 53266
France
Hôpital Pellegrin Enfants - CHU Bordeaux
Bordeaux, France, 33076
CRCM adultes et enfants Service des maladies respiratoires et pédiatrie 1 CHU- Arnaud de Villeneuve
Montpellier, France, 34295
Hôpital Cochin
Paris, France, 75014
Hôpital Necker-Enfants Malades
Paris, France, 75743
Hôpital Haut-Lévêque CHU de Bordeaux
Pessac, France, 33604
CRCM adulte Hôpital Larrey-CHU de Toulouse
Toulouse, France, 31059
Germany
Charité Campus Virchow-Klinikum
Berlin, Germany
Universitätskinderklinik Dresden Mukoviszidose-Ambulanz
Dresden, Germany
Universitätsklinikum Essen
Essen, Germany
Katharina-Kasper Kliniken GmbH St. Elisabethen-Krankenhaus Medizinische Klinik
Frankfurt, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Universitätsklinik Gießen und Marburg GmbH Zentrum für Kinderheilkunde und Jugendmedizin
Gieben, Germany
Kinderärztliche Gemeinschaftspraxis Dr. H. E. Heuer, Dr. C. Runge, W. Sextro
Hamburg, Germany
Universitätsklinikum Kiel
Kiel, Germany
Ludwig-Maximilians Universität Klinikum Innenstadt
Munchen, Germany
Dr. von Haunersches Kinderspital der Universität München Christiane Herzog Ambulanz
Munich, Germany
Universitätsklinik für Kinder- und Jugendmedizin
Tubingen, Germany
Ireland
Cork University Hospital
Cork, Ireland
National Children's Hospital Tallaght
Dublin, Ireland
St. Vincent's University Hospital
Dublin, Ireland
Beaumont Hospital
Dublin, Ireland
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
Safra Childrens Hospital, Sheba Medical Center
Ramat Gan, Israel, 52621
United Kingdom
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B95SS
Castle Hill Hospital
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
St James's University Hospital
Leeds, United Kingdom, LS97TF
King's College Hospital
London, United Kingdom, SE59RS
University Hospital Llandough, Penarth
Penarth, United Kingdom, CF64 2XX
Sponsors and Collaborators
Mpex Pharmaceuticals
Aptalis Pharma
Investigators
Principal Investigator: Patrick Flume, M.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Mpex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01270347     History of Changes
Other Study ID Numbers: Mpex-209
Study First Received: January 3, 2011
Last Updated: July 11, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
France: Ministry of Health
Ireland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Tobramycin
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