Trial record 2 of 5 for:
MPEX 376 and cystic fibrosis
Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients
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| ClinicalTrials.gov Identifier: NCT00677365 |
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Recruitment Status :
Completed
First Posted : May 14, 2008
Results First Posted : June 12, 2012
Last Update Posted : January 19, 2018
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Sponsor:
Horizon Pharma USA, Inc.
Information provided by (Responsible Party):
Horizon Pharma USA, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cystic Fibrosis (CF) | Drug: MP-376 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 151 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | June 2008 |
| Actual Primary Completion Date : | June 2009 |
| Actual Study Completion Date : | June 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Placebo inhaled either once or twice daily via the PARI eFlow nebulizer for 28 days
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Drug: Placebo
same frequency as study drug using the same nebulizer |
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Experimental: MP-376 120 mg QD
MP-376 120 mg inhaled Once Daily (QD) via the PARI eFlow nebulizer for 28 days
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Drug: MP-376
3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days
Other Names:
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Experimental: MP-376 240 mg QD
MP-376 240 mg inhaled QD bia the PARI eFlow nebulizer for 28 days
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Drug: MP-376
3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days
Other Names:
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Experimental: MP-376 240 mg BID
MP-376 240 mg inhaled twice daily (BID) via the PARI eFlow nebulizer for 28 days
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Drug: MP-376
3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days
Other Names:
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Primary Outcome Measures :
- Change in P. Aeruginosa Density [ Time Frame: from baseline to end of treatment (28 days) ]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
Secondary Outcome Measures :
- Time to Administration of Other Anti-pseudomonal Antimicrobials [ Time Frame: from baseline until final study visit (up to 56 days) ]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
- Percent Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: from baseline to end of the 28-day treatment period (28 days) ]Percent change in the amount of air the patient could exhale in 1 second
- Change in FEV1 Percent Predicted [ Time Frame: from baseline to the end of the treatment 28-day treatment period (28 days) ]Change in the predicted percent of air the patient could exhale in one second
- Changes in Respiratory Domain Scores of Cystic Fibrosis Questionnaire - Revised (CFQ-R) [ Time Frame: from baseline to the end of the 28-day treatment period (28 days) ]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
- Changes in Susceptability Patterns of Isolated Organisms [ Time Frame: from baseline until the end of the 28-day treatment period (28 days) ]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
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria (selected):
- > 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
Exclusion Criteria (selected):
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677365
Locations
Show 50 study locations
Sponsors and Collaborators
Horizon Pharma USA, Inc.
Investigators
| Principal Investigator: | Douglas J Conrad, M.D. | UCSD |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Horizon Pharma USA, Inc. |
| ClinicalTrials.gov Identifier: | NCT00677365 |
| Other Study ID Numbers: |
Mpex-204 2008-001728-30 ( EudraCT Number ) |
| First Posted: | May 14, 2008 Key Record Dates |
| Results First Posted: | June 12, 2012 |
| Last Update Posted: | January 19, 2018 |
| Last Verified: | January 2018 |
Additional relevant MeSH terms:
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Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Levofloxacin |
Anti-Infective Agents, Urinary Anti-Infective Agents Anti-Bacterial Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors |