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

A Multi-Center, Double-Blind, Placebo-Controlled Randomized, Efficacy and Safety Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease

The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.

Inclusion Criteria:

• Have confirmed diagnosis of cystic fibrosis
• Have FEV1 of greater than or equal to 75% 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 suggesting clinically significant active pulmonary disease
• Be colonized with Burkholderia cepacia
• Have had a lung transplant