Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories; Horizon Pharma USA, Inc.
• Collaborator: Forest Laboratories
• Treatments: Levofloxacin; Ofloxacin; Pharmaceutical Solutions; Tobramycin

Criteria

Inclusion Criteria (selected):

• > 12 years of age

• Confirmed Diagnosis of Cystic Fibrosis

• Positive sputum culture for P. aeruginosa within the past 12 months

• Patients are able to elicit an FEV1 >/= 25% butscreening

• Have received at least 3 courses of inhaled tobramycin 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 inhaled or systemic aminoglycosides including tobramycin or any excipients

• Evidence of acute upper within 10 days or lower respiratory infections within 28 days prior to dosing

• CrCl < 20 at Screening

• History of lung transplantation

Extension Portion of the Study: Patients enrolled in Mpex 209 are permitted to participate in the open label extension as long as they complete Visit 7 (Day 168), provide informed consent for participation in the open label extension of in the study and are clinically stable, as assessed by the Investigator.