Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients
Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients
2 other identifiers
interventional
151
3 countries
50
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2008
Shorter than P25 for phase_2
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2008
CompletedFirst Posted
Study publicly available on registry
May 14, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
June 12, 2012
CompletedDecember 27, 2024
December 1, 2024
1 year
May 12, 2008
September 4, 2011
December 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in P. Aeruginosa Density
Patients were required to cough deeply and then spit sputum into a sterile container. The bacteria contained in the sputum sample was incubated in a laboratory and the number of P. aeruginosa colony forming units per gram of sputum (CFU/g) was determined. The difference in CFUs/g were then compared from baseline to the conclusion of the 28 day treatment period
from baseline to end of treatment (28 days)
Secondary Outcomes (5)
Time to Administration of Other Anti-pseudomonal Antimicrobials
from baseline until final study visit (up to 56 days)
Percent Change in Forced Expiratory Volume in 1 Second (FEV1)
from baseline to end of the 28-day treatment period (28 days)
Change in FEV1 Percent Predicted
from baseline to the end of the treatment 28-day treatment period (28 days)
Changes in Respiratory Domain Scores of Cystic Fibrosis Questionnaire - Revised (CFQ-R)
from baseline to the end of the 28-day treatment period (28 days)
Changes in Susceptability Patterns of Isolated Organisms
from baseline until the end of the 28-day treatment period (28 days)
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo inhaled either once or twice daily via the PARI eFlow nebulizer for 28 days
MP-376 120 mg QD
EXPERIMENTALMP-376 120 mg inhaled Once Daily (QD) via the PARI eFlow nebulizer for 28 days
MP-376 240 mg QD
EXPERIMENTALMP-376 240 mg inhaled QD bia the PARI eFlow nebulizer for 28 days
MP-376 240 mg BID
EXPERIMENTALMP-376 240 mg inhaled twice daily (BID) via the PARI eFlow nebulizer for 28 days
Interventions
Eligibility Criteria
You may qualify if:
- \> 16 years of age
- 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
You may not qualify if:
- Use of any nebulized or systemic antibiotics within 30 days prior to baseline
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (50)
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Phoenix, Arizona, 85016, United States
Unknown Facility
Tucson, Arizona, 85724, United States
Unknown Facility
Little Rock, Arkansas, 72202, United States
Childrens Hospital
Los Angeles, California, 90027, United States
Unknown Facility
Los Angeles, California, 90033, United States
Unknown Facility
Oakland, California, 94611, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
Palo Alto, California, 94304, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Orlando, Florida, 32801, United States
Unknown Facility
Chicago, Illinois, 60025, United States
Unknown Facility
Oak Lawn, Illinois, 60453, United States
Unknown Facility
Park Ridge, Illinois, 60068, United States
Unknown Facility
Iowa City, Iowa, 52242, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
Ann Arbor, Michigan, 48109, United States
Unknown Facility
Kalamazoo, Michigan, 49007, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
Las Vegas, Nevada, 89107, United States
Unknown Facility
Morristown, New Jersey, 07962, United States
Unknown Facility
Albany, New York, 12208, United States
Unknown Facility
Valhalla, New York, 10595, United States
Unknown Facility
Cincinnati, Ohio, 45224, United States
Unknown Facility
Columbus, Ohio, 43205, United States
Unknown Facility
Dayton, Ohio, 45404, United States
Oklahoma CF Center
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Oklahoma City, Oklahoma, 73112, United States
Unknown Facility
Philadelphia, Pennsylvania, 19102, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Columbia, South Carolina, 29203, United States
Unknown Facility
Memphis, Tennessee, 38105, United States
Unknown Facility
San Antonio, Texas, 78212, United States
Unknown Facility
Tyler, Texas, 75708, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Berlin, Germany
Unknown Facility
Essen, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Gerlingen, Germany
Unknown Facility
Gieben, Germany
Unknown Facility
Kiel, Germany
Unknown Facility
München, Germany
Unknown Facility
Tübingen, Germany
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Groesbeek, Netherlands
Unknown Facility
Rotterdam, Netherlands
Related Publications (1)
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.
PMID: 21471106DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffery Nieves, PharmD, Senior Director
- Organization
- Horizon Pharma USA, Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2008
First Posted
May 14, 2008
Study Start
June 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
December 27, 2024
Results First Posted
June 12, 2012
Record last verified: 2024-12