Cystic Fibrosis Foundation - Click here for homepage
Stay Informed  |  Volunteer  |  Clinical Trials

In This Section

Quick Links

Find a Chapter

Print  

Study Name: Inhaled Levofloxacin (MP-376) in CF Patients with P. aeruginosa (Phase 2 Study)
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Mpex
Study Phase: 2
Recruitment Status: Trial Completed
Study Drug(s): Levofloxacin (Inhaled)
Number of Participants Being Recruited: 140
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
MP-376 is a form of levofloxacin being developed to be inhaled to control chronic pulmonary infections due to Pseudomonas aeruginosa and other bacteria. It uses the PARI eFlow nebulizer. Early preclinical and clinical studies shows that MP376 achieves high levofloxacin concentrations in pulmonary tissues that are much higher than those achieved with pills taken by mouth. The high concentrations of levofloxacin delivered using aerosol MP376 are likely to provide strong antimicrobial effects against key bacteria in CF patients, including those resistant to other classes of drugs (e.g., tobramycin and aztreonam).
ELIGIBILITY
Age: >= 16 Years
FEV1: 25 - 75 Percent Predicted
P. aeruginosa status: Positive
B. cepacia status: Negative
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information: Loutit, Jeff
(858) 875-6665
jloutit@rempexpharma.com
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00677365?term=MPEX+376+and+cystic+fibrosis&rank=2
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

This study enrolled 151 CF patients to evaluate the safety, tolerability and efficacy of three dose levels of inhaled Aeroquin (120mg given once daily, 240 mg given once daily and 240 mg given twice daily) administered for 28 days. The trial met the primary endpoint of a reduction in sputum Pseudomonas aeruginosa density at Day 28, the end of treatment. All three doses of Aeroquin demonstrated statistical significance (p < 0.01 for each group versus placebo), with the highest dose (240 mg BID) showing the greatest effect of approximately 1 log reduction.

Secondary Efficacy:

Statistically significant improvements in respiratory function and reduction in the need for other antibiotics were also demonstrated in the trial.

Safety:

The percent of patients with adverse events (AEs) was similar across all treatment groups, with no evidence of increasing incidence or severity of AEs with increasing Aeroquin dose.

Citation:

Am J Respir Crit Care Med 2011;183(11):1510-1516

Back to top