A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, 28-DAY STUDY OF DENUFOSOL TETRAS

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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. The objectives of this study are to evaluate the safety and tolerability of two dose levels of Denufosol (INS37217) Inhalation Solution compared to palcebo administered three times daily over 28 days in patients with CF lung disease age 5 to 7 years of age. A second objective is to gain preliminary evidence of efficacy in this age group. In addition, the study will assess the feasibility of conducting this type of study is patients in this younger age group.