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



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:1/21/2018
Start Date:January 2011
End Date:June 2013

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Phase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable CF 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. 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.

This study will assess the comparative safety of MP-376 (Aeroquin) and Tobramycin Inhalation
solution (TIS) [TOBI® Novartis Pharmaceuticals] over three consecutive cycles of 28-days
treatment followed by 28-days off in stable CF patients with chronic P. aeruginosa lung
infection. Efficacy data for MP-376 and TIS at the end of the first 28-day treatment period
will also be compared, as well as explored over multiple treatment cycles.

Study patients participating in Mpex 209 will be given the option to participate in a
six-month open label extension phase of the Mpex 209 protocol. The open label extension will
allow enrolled patients to receive three additional courses of MP-376 (levofloxacin
inhalation solution, Aeroquin™).

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% but screening

- 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.
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