Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease
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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.
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Ages Eligible for Study:
8 Years to 50 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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