Conditions: Cystic Fibrosis (CF)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 151
Healthy volunteers: no

Brief 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.

Detailed 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.

Arms:
arm 1: Placebo inhaled either once or twice daily via the PARI eFlow nebulizer for 28 days arm 2: MP-376 120 mg inhaled Once Daily (QD) via the PARI eFlow nebulizer for 28 days arm 3: MP-376 240 mg inhaled QD bia the PARI eFlow nebulizer for 28 days arm 4: MP-376 240 mg inhaled twice daily (BID) via the PARI eFlow nebulizer for 28 days

Interventions: intervention 1: MP-376 intervention 2: Placebo
Intervention descriptions: intervention 1: 3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days intervention 2: same frequency as study drug using the same nebulizer

Protocol document: