NCT00677365

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

Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis (CF)

Interventions

Type	Name	Description
DRUG	MP-376	3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days
DRUG	Placebo	same frequency as study drug using the same nebulizer

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-05-14
• Last updated: 2024-12-27
• Results posted: 2012-06-12

Locations

50 sites across 3 countries: United States, Germany, Netherlands