Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 5 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2008 |
| End Date: | October 2010 |
A Phase 3, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease and FEV1 Greater Than or Equal to 75% Predicted But Less Than or Equal to 110% Predicted
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.
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.
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
Exclusion Criteria:
- Have abnormal renal or liver function
- Have lung transplant
- Unable to discontinue use of hypertonic saline
- Participated in Inspire trial 08-108
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