Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT00677365
Study type Interventional
Source Horizon Pharma USA, Inc.
Contact
Status Completed
Phase Phase 2
Start date June 2008
Completion date June 2009

See also
  Status Clinical Trial Phase
Terminated NCT04853368 - Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Adult Participants With Cystic Fibrosis Phase 2
Terminated NCT03234387 - A CFit Study - Baseline
Completed NCT03445793 - : TRANSITION: An Observational Study of Transition From Lumacaftor/Ivacaftor to Tezacaftor/Ivacaftor (Tez/Iva)
Completed NCT02778750 - Evaluation Of The Pan-microbiome and Host Immune Response in CF
Terminated NCT03597347 - Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection Phase 2
Recruiting NCT05818319 - Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/Tezacaftor/Ivacaftor in Urine After a Short Pause of Therapy N/A
Completed NCT04375878 - OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis Phase 2
Withdrawn NCT01951833 - Long Term Significance (Survival) of LCI in Patients With Cystic Fibrosis N/A
Completed NCT03746483 - OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis Phase 2
Completed NCT02163681 - MRI for Non-Invasive Imaging in Neonates and Children N/A
Completed NCT02036879 - Gender Disparity and Hormones in Cystic Fibrosis Early Phase 1
Completed NCT02605590 - Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult Volunteers Phase 1
Recruiting NCT01851642 - Lung Disease and Its Affect on the Work of White Blood Cells in the Lungs