Trial record 1 of 5 for:    mpex and cystic fibrosis
Previous Study | Return to List | Next Study

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

August 10, 2010
July 11, 2013
November 2010
July 2012   (final data collection date for primary outcome measure)
Time to an exacerbation [ Time Frame: 56 days ] [ Designated as safety issue: No ]
Time to an exacerbation from baseline to end of treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01180634 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Changes in respiratory and other domains of CFQ-R from baseline to end of treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Time to administration of other anti-pseudomonal antimicrobials [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Evaluate changes in FEV1 and FVC from baseline to end of treatment [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Changes in bacterial load and susceptability patterns of isolated organisms from 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: Yes ]
Not Provided
Not Provided
 
MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cystic Fibrosis
  • Drug: MP-376 (Levofloxacin solution for Inhalation)
    240 mg of MP-376 administered BID for 28 days
  • Drug: Placebo
    same volume and frequency as study drug
  • Experimental: 1
    Inhaled MP-376 (Aeroquin)
    Intervention: Drug: MP-376 (Levofloxacin solution for Inhalation)
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
September 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Israel,   New Zealand
 
NCT01180634
Mpex-207
Yes
Mpex Pharmaceuticals
Mpex Pharmaceuticals
Aptalis Pharma
Principal Investigator: Patrick Flume, M.D. MUSC
Mpex Pharmaceuticals
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP