Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients
NCT ID: NCT00677365
Last Updated: 2024-12-27
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
PHASE2
151 participants
INTERVENTIONAL
2008-06-30
2009-06-30
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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Placebo
Placebo inhaled either once or twice daily via the PARI eFlow nebulizer for 28 days
Placebo
same frequency as study drug using the same nebulizer
MP-376 120 mg QD
MP-376 120 mg inhaled Once Daily (QD) via the PARI eFlow nebulizer for 28 days
MP-376
3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days
MP-376 240 mg QD
MP-376 240 mg inhaled QD bia the PARI eFlow nebulizer for 28 days
MP-376
3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days
MP-376 240 mg BID
MP-376 240 mg inhaled twice daily (BID) via the PARI eFlow nebulizer for 28 days
MP-376
3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days
Interventions
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MP-376
3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days
Placebo
same frequency as study drug using the same nebulizer
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 18 months
* Patients are able to elicit a forced expiratory volume in 1 second (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 30 days
* Able to reproducibly produce sputum and perform spirometry
Exclusion Criteria
* History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
* Evidence of acute upper within 10 days or lower respiratory infections within 30 days prior to dosing
* Creatine clearance \< 50mg/ml, aspartate transaminase (AST), alanine transaminase (ALT) or total bilirubin \>/= 3 x upper limit of normal (ULN) at Screening
16 Years
ALL
No
Sponsors
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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
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, 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
Miami, Florida, United States
Orlando, Florida, United States
Chicago, Illinois, United States
Oak Lawn, Illinois, United States
Park Ridge, Illinois, United States
Iowa City, Iowa, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Kalamazoo, Michigan, United States
Minneapolis, Minnesota, United States
Las Vegas, Nevada, United States
Morristown, New Jersey, United States
Albany, New York, United States
Valhalla, New York, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Oklahoma CF Center
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Memphis, Tennessee, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Salt Lake City, Utah, United States
Berlin, , Germany
Essen, , Germany
Frankfurt, , Germany
Gerlingen, , Germany
Gieben, , Germany
Kiel, , Germany
München, , Germany
Tübingen, , Germany
Amsterdam, , Netherlands
Groesbeek, , Netherlands
Rotterdam, , Netherlands
Countries
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References
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Geller DE, Flume PA, Staab D, Fischer R, Loutit JS, Conrad DJ; Mpex 204 Study Group. Levofloxacin inhalation solution (MP-376) in patients with cystic fibrosis with Pseudomonas aeruginosa. Am J Respir Crit Care Med. 2011 Jun 1;183(11):1510-6. doi: 10.1164/rccm.201008-1293OC. Epub 2011 Feb 25.
Other Identifiers
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2008-001728-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Mpex-204
Identifier Type: -
Identifier Source: org_study_id