Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease

Inclusion Criteria:

• Have confirmed diagnosis of CF
• Have an FEV1 greater than or equal to 60% or less than or equal to 90% of predicted normal
• Have oxygen saturation greater than or equal to 90% on room air
• Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation
• Be able to reproducibly perform spirometry maneuvers

Exclusion Criteria:

• Have changed their physiotherapy technique or schedule within 7 days prior to screening
• Have clinically significant comorbidities
• Using prior and concurrent medications according to the protocol