MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
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Purpose
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. Decreased efficacy, intolerance and high treatment burden with currently available therapies indicate a need for additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active against CF pathogens including those with high minimum inhibitory concentration (MIC) levels to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered rapidly and efficiently using a customized PARI investigational configuration of the eFlow® nebulizer system.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis |
Drug: MP-376 (Levofloxacin solution for Inhalation) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) In Stable Cystic Fibrosis Patients |
- Time to an exacerbation [ Time Frame: 56 days ] [ Designated as safety issue: No ]
- Time to administration of other anti-pseudomonal antimicrobials [ Time Frame: 56 days ] [ Designated as safety issue: No ]
- Evaluate changes in FEV1, FEF 25-75 and FVC from baseline to end of treatment [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Changes in bacterial load and susceptibility patterns of isolated organisms from baseline to end of treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Changes in respiratory domain of CFQ-R from baseline to end of treatment baseline to end of treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Evaluate the safety of MP-376 administered over 28 days, compared to placebo [ Time Frame: 56 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 330 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Inhaled MP-376 (Aeroquin)
|
Drug: MP-376 (Levofloxacin solution for Inhalation)
240 mg of MP-376 administered BID for 28 days
|
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo
same volume and frequency as study drug
|
Detailed Description:
This trial will be a double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin administered as MP-376 given for 28 days by the aerosol route to CF patients.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria (selected):
- >/= 12 years of age
- 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 (selected):
- Use of any nebulized or systemic antibiotics within 28 days prior to baseline
- 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
Contacts and Locations
Show 112 Study Locations| Principal Investigator: | Patrick Flume, M.D. | MUSC |
More Information
No publications provided
| Responsible Party: | Mpex Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01180634 History of Changes |
| Other Study ID Numbers: | Mpex-207 |
| Study First Received: | August 10, 2010 |
| Last Updated: | June 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cystic Fibrosis Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes Ofloxacin |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |
ClinicalTrials.gov processed this record on May 19, 2013