Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease

A Randomized, Double-Blind, Two Way Crossover Evaluation of the Effects of a Single Dose of Denufosol Tetrasodium (INS37217) Inhalation Solution Versus Placebo (0.9% Sodium Chloride Solution) on Mucociliary Clearance in Patients With Mild to Moderate Cystic Fibrosis Lung Disease

The purpose of this trial is to evaluate the effects of a single dose of denufosol versus placebo on mucociliary clearance in patients with mild to moderate CF lung disease

Inclusion Criteria:

• have confirmed diagnosis of cystic fibrosis
• have FEV1 of greater than or equal to 60% of predicted normal for age, gender, and height
• be able to reproducibly perform spirometry maneuvers
• be clinically stable for at least 4 weeks prior to screening

Exclusion Criteria:

• have abnormal renal or liver function
• have chest x-ray at screening with abnormalities suggesting clinically significant active pulmonary disease
• have had a lung transplant