Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients

Amgen

Status and phase: Completed; Phase 2

Conditions: Cystic Fibrosis (CF)

Treatments: Drug: Placebo; Drug: MP-376

Study type: Interventional

Funder types: Industry

Identifiers

NCT00677365

Mpex-204

2008-001728-30 (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 trial will be a double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of levofloxacin administered as MP-376 of three dosage regimens given for 28 days by the aerosol route to CF patients.

Study with completed results acquired from Horizon in 2024.

Enrollment: 151 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (selected):

• > 16 years of age
• Confirmed Diagnosis of Cystic Fibrosis
• Positive sputum culture for P. aeruginosa within the past 18 months
• Patients are able to elicit a forced expiratory volume in 1 second (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 30 days
• Able to reproducibly produce sputum and perform spirometry

Exclusion Criteria (selected):

• Use of any nebulized or systemic antibiotics within 30 days prior to baseline
• History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
• Evidence of acute upper within 10 days or lower respiratory infections within 30 days prior to dosing
• Creatine clearance < 50mg/ml, aspartate transaminase (AST), alanine transaminase (ALT) or total bilirubin >/= 3 x upper limit of normal (ULN) at Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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151 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo inhaled either once or twice daily via the PARI eFlow nebulizer for 28 days

Treatment:

Drug: Placebo

MP-376 120 mg QD

Experimental group

Description:

MP-376 120 mg inhaled Once Daily (QD) via the PARI eFlow nebulizer for 28 days

Treatment:

Drug: MP-376

MP-376 240 mg QD

Experimental group

Description:

MP-376 240 mg inhaled QD bia the PARI eFlow nebulizer for 28 days

Treatment:

Drug: MP-376

MP-376 240 mg BID

Experimental group

Description:

MP-376 240 mg inhaled twice daily (BID) via the PARI eFlow nebulizer for 28 days

Treatment:

Drug: MP-376