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

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ClinicalTrials.gov Identifier: NCT01180634
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : January 19, 2018
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Horizon Pharma USA, Inc.

Study Description
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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. 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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: MP-376 (Levofloxacin solution for Inhalation) Drug: Placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Time to an exacerbation [ Time Frame: 56 days ]

Secondary Outcome Measures :
  1. Time to administration of other anti-pseudomonal antimicrobials [ Time Frame: 56 days ]
  2. Evaluate changes in FEV1, FEF 25-75 and FVC from baseline to end of treatment [ Time Frame: 28 days ]
  3. Changes in bacterial load and susceptibility patterns of isolated organisms from baseline to end of treatment [ Time Frame: 28 days ]
  4. Changes in respiratory domain of CFQ-R from baseline to end of treatment baseline to end of treatment [ Time Frame: 28 days ]
  5. Evaluate the safety of MP-376 administered over 28 days, compared to placebo [ Time Frame: 56 days ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT01180634


Locations
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Sponsors and Collaborators
Horizon Pharma USA, Inc.
Forest Laboratories
Investigators
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Principal Investigator: Patrick Flume, M.D. Medical University of South Carolina
More Information
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Responsible Party: Horizon Pharma USA, Inc.
ClinicalTrials.gov Identifier: NCT01180634    
Other Study ID Numbers: Mpex-207
2010-019515-38 ( EudraCT Number )
First Posted: August 12, 2010    Key Record Dates
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
Ofloxacin
 Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal 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