MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
NCT ID: NCT01180634
Last Updated: 2024-12-18
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
330 participants
INTERVENTIONAL
2010-11-04
2012-05-07
Brief Summary
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Detailed Description
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Study with completed results acquired from Horizon in 2024.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Aeroquin 240 mg
Participants received 240 milligrams (mg) of Aeroquin by inhalation route twice daily (BID) for a period of 28 days.
Aeroquin
Inhalation Solution
Placebo
Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.
Placebo
Inhalation Solution
Interventions
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Aeroquin
Inhalation Solution
Placebo
Inhalation Solution
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 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
* 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
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
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 Francisco, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Hartford, Connecticut, United States
Wilmington, Delaware, 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
Indianapolis, Indiana, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Portland, Maine, 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
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
Long Branch, New Jersey, United States
Morristown, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
New York, 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
Chapel Hill, 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 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
Seattle, Washington, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
John Hunter Hospital
New South Wales, New South Wales, Australia
Westmead Chilren's Hospital
Westmead, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Mater Miscericordiae Hospital
Brisbane, Queensland, Australia
Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Children's Hospital
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Monash Medical Center
Melbourne, , Australia
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
Ottawa, Ontario, Canada
Rambam Medical Center
Haifa, , Israel
Hadassah Medical Center Mount Scopus
Jerusalem, , Israel
Schneider Childrens Medical Center of Israel
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Auckland Hospital
Auckland, , New Zealand
Countries
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Other Identifiers
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2010-019515-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Mpex-207
Identifier Type: -
Identifier Source: org_study_id