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

Amgen

Status and phase: Completed; Phase 3

Conditions: Cystic Fibrosis

Treatments: Drug: TIS (Tobramycin Inhalation Solution); Drug: MP-376 (Levofloxacin Solution for Inhalation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01270347

Mpex-209

2010-019634-26 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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™).

Study with completed results acquired from Horizon in 2024.

Enrollment: 282 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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% but </= 85% of predicted value at 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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282 participants in 2 patient groups

Aeroquin

Experimental group

Description:

Aeroquin, Inhaled Levofloxacin (MP-376)

Treatment:

Drug: MP-376 (Levofloxacin Solution for Inhalation)

TIS

Active Comparator group

Description:

Tobramycin Inhalation solution (TIS) \[TOBI® Novartis Pharmaceuticals\]

Treatment:

Drug: TIS (Tobramycin Inhalation Solution)