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Therapeutic Areas: Pulmonary/Respiratory Diseases
Disease Category: Cystic Fibrosis
Trial Information
Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease
The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.
Patient Inclusion Criteria:
- Have confirmed diagnosis of cystic fibrosis
- Have FEV1 of greater than or equal to 75% but less than or equal to 110%predicted normal for age, gender and height
- Be able to reproducibly perform spirometry
- Be clinically stable for at least 4 weeks before screening
Patient Exclusion Criteria:
- Have abnormal renal or liver function
- Have lung transplant
- Unable to discontinue use of hypertonic saline
- Participated in Inspire trial 08-108
Kelly Colucci, Manager, Grants and Contracts
Atlantic Health System
475 South Street
Morristown, NJ 07962
Phone: 973-660-3139
EMail: kelly.colucci@atlantichealth.org
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Research Center Information: Atlantic Health System
If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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