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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001728-30 | EudraCT Number |
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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.
This trial will be a double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of levofloxacin administered as MP-376 of three dosage regimens given for 28 days by the aerosol route to CF patients.
Study with completed results acquired from Horizon in 2024.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo inhaled either once or twice daily via the PARI eFlow nebulizer for 28 days |
|
| MP-376 120 mg QD | Experimental | MP-376 120 mg inhaled Once Daily (QD) via the PARI eFlow nebulizer for 28 days |
|
| MP-376 240 mg QD | Experimental | MP-376 240 mg inhaled QD bia the PARI eFlow nebulizer for 28 days |
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| MP-376 240 mg BID | Experimental | MP-376 240 mg inhaled twice daily (BID) via the PARI eFlow nebulizer for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP-376 | Drug | 3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Administration of Other Anti-pseudomonal Antimicrobials | Time to administration of other anti-pseudomonal antimicrobials in patients with at least one of the following: decreased exercise tolerance, increased cough, increased sputum/chest congestion, or decreased appetite; 25th percentile data reported | from baseline until final study visit (up to 56 days) |
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Inclusion Criteria (selected):
Exclusion Criteria (selected):
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36608 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21471106 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo Group |
| FG001 | MP-376 120 mg QD | MP-376 120 mg Once Daily (QD) Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | same frequency as study drug using the same nebulizer |
|
| Percent Change in Forced Expiratory Volume in 1 Second (FEV1) | Percent change in the amount of air the patient could exhale in 1 second | from baseline to end of the 28-day treatment period (28 days) |
| Change in FEV1 Percent Predicted | Change in the predicted percent of air the patient could exhale in one second | 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) | Change in the score from 0 to 100 that a patient reports for their respiratory symptoms in the CFQ-R. An increase in score illustrates an improvement in symptoms. An increase of 4 or more is considered clinically significant | from baseline to the end of the 28-day treatment period (28 days) |
| Changes in Susceptability Patterns of Isolated Organisms | All isolates of P. aeruginosa cultures grown from patient sputum samples were evaluated to see whether the minimum concentration of levofloxacin needed to inhibit growth of the bacteria (i.e., minimum inhibitory concentration; MIC) had increased; 2. The MIC50 and MIC90 values were calculated as the 50th percentile value and the 90th percentile value, respectively. Note that percentile values between dilution values were rounded up to the nearest dilution value | from baseline until the end of the 28-day treatment period (28 days) |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Tucson | Arizona | 85724 | United States |
| Little Rock | Arkansas | 72202 | United States |
| Childrens Hospital | Los Angeles | California | 90027 | United States |
| Los Angeles | California | 90033 | United States |
| Oakland | California | 94611 | United States |
| Orange | California | 92868 | United States |
| Palo Alto | California | 94304 | United States |
| Sacramento | California | 95817 | United States |
| San Diego | California | 92103 | United States |
| Miami | Florida | 33136 | United States |
| Orlando | Florida | 32801 | United States |
| Chicago | Illinois | 60025 | United States |
| Oak Lawn | Illinois | 60453 | United States |
| Park Ridge | Illinois | 60068 | United States |
| Iowa City | Iowa | 52242 | United States |
| Louisville | Kentucky | 40202 | United States |
| Boston | Massachusetts | 02115 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Kalamazoo | Michigan | 49007 | United States |
| Minneapolis | Minnesota | United States |
| Las Vegas | Nevada | 89107 | United States |
| Morristown | New Jersey | 07962 | United States |
| Albany | New York | 12208 | United States |
| Valhalla | New York | 10595 | United States |
| Cincinnati | Ohio | 45224 | United States |
| Columbus | Ohio | 43205 | United States |
| Dayton | Ohio | 45404 | United States |
| Oklahoma CF Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Philadelphia | Pennsylvania | 19102 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Charleston | South Carolina | 29425 | United States |
| Columbia | South Carolina | 29203 | United States |
| Memphis | Tennessee | 38105 | United States |
| San Antonio | Texas | 78212 | United States |
| Tyler | Texas | 75708 | United States |
| Salt Lake City | Utah | 84132 | United States |
| Berlin | Germany |
| Essen | Germany |
| Frankfurt | Germany |
| Gerlingen | Germany |
| Gieben | Germany |
| Kiel | Germany |
| München | Germany |
| Tübingen | Germany |
| Amsterdam | Netherlands |
| Groesbeek | Netherlands |
| Rotterdam | Netherlands |
| FG002 |
| MP-376 240 mg QD |
MP-376 240 mg Once Daily (QD) Group |
| FG003 | MP-376 240 mg BID | MP-376 240 mg Twice Daily (BID) Group |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Group |
| BG001 | MP-376 120 mg QD | MP-376 120 mg Once Daily (QD) Group |
| BG002 | MP-376 240 mg QD | MP-376 240 mg Once Daily (QD) Group |
| BG003 | MP-376 240 mg BID | MP-376 240 mg Twice Daily (BID) Group |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Modified Intent-to-Treat (MITT; patients who received at least one dose of study drug) | Posted | Least Squares Mean | Standard Error | log10 CFU/g sputum | from baseline to end of treatment (28 days) |
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| Secondary | Time to Administration of Other Anti-pseudomonal Antimicrobials | Time to administration of other anti-pseudomonal antimicrobials in patients with at least one of the following: decreased exercise tolerance, increased cough, increased sputum/chest congestion, or decreased appetite; 25th percentile data reported | MITT | Posted | Mean | 95% Confidence Interval | days | from baseline until final study visit (up to 56 days) |
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| Secondary | Percent Change in Forced Expiratory Volume in 1 Second (FEV1) | Percent change in the amount of air the patient could exhale in 1 second | MITT | Posted | Least Squares Mean | Standard Error | Percent change | from baseline to end of the 28-day treatment period (28 days) |
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| Secondary | Change in FEV1 Percent Predicted | Change in the predicted percent of air the patient could exhale in one second | MITT | Posted | Least Squares Mean | Standard Error | Percent | from baseline to the end of the treatment 28-day treatment period (28 days) |
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| Secondary | Changes in Respiratory Domain Scores of Cystic Fibrosis Questionnaire - Revised (CFQ-R) | Change in the score from 0 to 100 that a patient reports for their respiratory symptoms in the CFQ-R. An increase in score illustrates an improvement in symptoms. An increase of 4 or more is considered clinically significant | MITT | Posted | Least Squares Mean | Standard Error | units on a scale | from baseline to the end of the 28-day treatment period (28 days) |
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| Secondary | Changes in Susceptability Patterns of Isolated Organisms | All isolates of P. aeruginosa cultures grown from patient sputum samples were evaluated to see whether the minimum concentration of levofloxacin needed to inhibit growth of the bacteria (i.e., minimum inhibitory concentration; MIC) had increased; 2. The MIC50 and MIC90 values were calculated as the 50th percentile value and the 90th percentile value, respectively. Note that percentile values between dilution values were rounded up to the nearest dilution value | MITT | Posted | Number | ug/mL | from baseline until the end of the 28-day treatment period (28 days) | Isolates | Isolates |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo Group | 4 | 37 | 28 | 37 | ||
| EG001 | MP-376 120 mg QD | MP-376 120 mg Once Daily (QD) Group | 1 | 38 | 33 | 38 | ||
| EG002 | MP-376 240 mg QD | MP-376 240 mg Once Daily (QD) Group | 4 | 37 | 32 | 37 | ||
| EG003 | MP-376 240 mg BID | MP-376 240 mg Twice Daily (BID) Group | 4 | 39 | 33 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease progression | General disorders | MedDRA | Systematic Assessment | Pulmonary exacerbation |
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| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment | Taste complaint |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Disease progression | General disorders | MedDRA | Systematic Assessment | Pulmonary exacerbation |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Pharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Chest Discomfort | General disorders | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffery Nieves, PharmD, Senior Director | Horizon Pharma USA, Inc. | clinicaltrials@horizonpharma.com |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| Europe |
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