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| ID | Type | Description | Link |
|---|---|---|---|
| 08-114 |
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The purpose of this study is to obtain data on the potential of long-term treatment with denufosol to improve the clinical course of CF lung disease in patients with mildly impaired lung function and to provide CF patients who completed study 08-110 continued access to denufosol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denufosol tetrasodium Inhalation Solution | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denufosol tetrasodium Inhalation Solution | Drug | 60 mg by oral inhalation three times daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of change in lung function, as measured by change in FEV1 | 160 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in absolute FEV1 from baseline | Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160 | |
| Change in FEV1 percent predicted value from baseline | Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynn Smiley, MD | Medical Monitor | Study Director |
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| Change in FEF25%-75% and forced vital capacity (FVC) from baseline |
| Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160 |
| Incidence of pulmonary exacerbations | 160 Weeks |
| Changes in Pseudomonas aeruginosa status | 160 Weeks |
| Number of days of intravenous (IV) antibiotic use for a respiratory complaint | 160 Weeks |
| Incidence of hospitalizations/Emergency room (ER) visits for a respiratory complaint | 160 Weeks |
| Number of days hospitalized for a respiratory complaint | 160 Weeks |
| Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs | 160 Weeks |
| Incidence of patients with significant decrease in absolute FEV1 at any visit from baseline | 160 Weeks |
| Changes in physical exam findings including height, weight, and body mass index from baseline | Weeks 48, 96, and 160 |
| Changes in hematology, serum chemistry, and urinalysis parameters from baseline | Weeks 24, 48, 72, 96, 120, 144, and 160 |
| Incidence of hospitalizations/ER visits | 160 Weeks |
| Incidence of early discontinuations from the study | 160 Weeks |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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