Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Cystic Fibrosis Lung Disease

The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) 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