Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients
NCT ID: NCT01270347
Last Updated: 2024-12-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
282 participants
INTERVENTIONAL
2011-01-31
2013-06-30
Brief Summary
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Detailed Description
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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™).
Study with completed results acquired from Horizon in 2024.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Aeroquin
Aeroquin, Inhaled Levofloxacin (MP-376)
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
TIS
Tobramycin Inhalation solution (TIS) \[TOBI® Novartis Pharmaceuticals\]
TIS (Tobramycin Inhalation Solution)
Tobramycin Inhalation Solution administered BID over 3 consecutive cycles of 28-days treatment followed by 28 days off treatment
Interventions
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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
TIS (Tobramycin Inhalation Solution)
Tobramycin Inhalation Solution administered BID over 3 consecutive cycles of 28-days treatment followed by 28 days off treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Mobile, Alabama, United States
Anchorage, Alaska, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
La Jolla, California, United States
Long Beach, California, United States
Childrens Hospital
Los Angeles, California, United States
Los Angeles, California, United States
Oakland, California, United States
Orange, California, United States
Palo Alto, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Hartford, Connecticut, United States
New Haven, Connecticut, United States
Wilmington, Delaware, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Glenview, Illinois, United States
Niles, Illinois, United States
Peoria, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Portland, Maine, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Minneapolis, Minnesota, United States
Jackson, Mississippi, United States
Columbia, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Lebanon, New Hampshire, United States
Manchester, New Hampshire, United States
Livingston, New Jersey, United States
Morristown, New Jersey, United States
Albuquerque, New Mexico, United States
Albany Medical College #2
Albany, New York, United States
Albany, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
New York, New York, United States
Syracuse, New York, United States
Valhalla, New York, United States
Durham, North Carolina, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Toledo, Ohio, United States
Oklahoma CF Center
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Sioux Falls, South Dakota, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Salt Lake City, Utah, United States
Colchester, Vermont, United States
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Portsmouth, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
Milwaukee, Wisconsin, United States
Hôpital Pellegrin Enfants - CHU Bordeaux
Bordeaux, , France
CRCM adultes et enfants Service des maladies respiratoires et pédiatrie 1 CHU- Arnaud de Villeneuve
Montpellier, , France
Hôpital Cochin
Paris, , France
Hôpital Necker-Enfants Malades
Paris, , France
Hôpital Haut-Lévêque CHU de Bordeaux
Pessac, , France
CRCM adulte Hôpital Larrey-CHU de Toulouse
Toulouse, , France
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
Dr. von Haunersches Kinderspital der Universität München Christiane Herzog Ambulanz
Munich, , Germany
Ludwig-Maximilians Universität Klinikum Innenstadt
München, , Germany
Universitätsklinik für Kinder- und Jugendmedizin
Tübingen, , Germany
Cork University Hospital
Cork, , Ireland
Beaumont Hospital
Dublin, , Ireland
National Children's Hospital Tallaght
Dublin, , Ireland
St. Vincent's University Hospital
Dublin, , Ireland
Rambam Medical Center
Haifa, , Israel
Hadassah Medical Center Mount Scopus
Jerusalem, , Israel
Schneider Childrens Medical Center of Israel
Petah Tikva, , Israel
Safra Childrens Hospital, Sheba Medical Center
Ramat Gan, , Israel
Belfast City Hospital
Belfast, , United Kingdom
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Castle Hill Hospital
Cottingham, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
King's College Hospital
London, , United Kingdom
University Hospital Llandough, Penarth
Penarth, , United Kingdom
Countries
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References
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Elborn JS, Flume PA, Cohen F, Loutit J, VanDevanter DR. Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. J Cyst Fibros. 2016 Sep;15(5):634-40. doi: 10.1016/j.jcf.2016.01.005. Epub 2016 Feb 28.
Other Identifiers
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2010-019634-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Mpex-209
Identifier Type: -
Identifier Source: org_study_id