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MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis

This study has been completed.
Sponsor:
Collaborator:
Aptalis Pharma
Information provided by (Responsible Party):
Mpex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01180634
First received: August 10, 2010
Last updated: July 11, 2013
Last verified: July 2013
  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

Resource links provided by NLM:


Further study details as provided by Mpex Pharmaceuticals:

Primary Outcome Measures:
  • Time to an exacerbation [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 330
Study Start Date: November 2010
Study Completion Date: September 2012
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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180634

  Show 112 Study Locations
Sponsors and Collaborators
Mpex Pharmaceuticals
Aptalis Pharma
Investigators
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: July 11, 2013
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 April 17, 2014