CLINICAL TRIAL: TETRASODIUM IN PATIENTS WITH MILD CYSTIC FIBROSIS LUNG DISEASE

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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. This is a multicenter, randomized, double-blind, placebo-controlled Phase III study that will examine denufosol as an early intervention therapy to improve lung function relative to placebo in a relatively healthy Cystic Fibrosis (CF) patient population. Eligible patients will be randomized to receive either denufosol 60 mg or placebo three times daily for a 24-week treatment period. At the completion of the 24-week placebo-controlled portion of this study, all patients will receive 60 mg denufosol three times daily for an additional 24 weeks in a safety extension period. The purpose of this study is to investigate the safety and effectiveness of one dose strength of denufosol compared to placebo in patients with mild CF lung disease. The placebo in this study is a sterile saline (salt water) solution. Another purpose of this study is to determine how the body absorbs and processes denufosol compared to placebo. This part of the study will determine if there are levels of denufosol that can be measured in the blood (PK= pharmacokinetics) after breathing in denufosol inhalation solution during the first half of the study.