CLINICAL TRIAL: PARI EFLOW? ELECTRONIC NEBULIZER TO STABLE CYSTIC FIBROSIS PATIE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Cystic fibrosis (CF) is a recessive genetic disease that affects approximately 30,000 children and adults in the United States. Despite progress in the treatment of CF, there is no cure. The predicted median approximate age of survival for a person with CF is the mid-30s. Patients with CF suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa (Pa), which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Levofloxacin is a medicine already approved by the FDA for the treatment of certain types of bacterial infections. Currently, Levofloxacin is generally given as tablets or by injection into a vein. Mpex Pharmaceuticals made a solution of Levofloxacin MP-376 specially made for inhalation. The Mpex company is testing to see if Levofloxacin can be given safely, efficiently, and effectively to patients with CF as an inhaled medication. The Levofloxacin will be nebulized through the PARI Eflow¿ for participants to breathe in. In this study, there will be three doses studied. The study subject population of this study is Male and female with CF, 16 years of age or older. This is a Phase I, Randomized, Single-Blind, Placebo-Controlled Clinical Study.