Studies Open for Enrollment

A Study of Denufosol Tetrasodium Inhalation Solution in Patients with Mild Cystic Fibrosis Lung Disease

The primary purpose of this study is to investigate the safety and effectiveness of one-dose strength of denufosol tetrasodium in patients with mild Cystic Fibrosis (CF) lung disease. Denufosol tetrasodium might improve the body’s ability to clear mucus from the lungs of patients early in the disease development, which may preserve lung function and lessen the repeat cycles of lung infection and chronic lung function decline. Participants will be randomly assigned to receive either inhaled denufosol tetrasodium or an inhaled placebo by aerosol for six months. At the 6-month interval, participants will be given inhaled denufosol by aerosol for the remaining 6 months.

Approximately 350 patients will be participating in this research study from about 70 sites across the United States, with 15 enrollees from the Pediatric Clinical and Translational Research Center at Children’s Hospital of Pittsburgh of UPMC.

Candidates
Children with cystic fibrosis, 5 years of age and older who have mild lung disease, are invited to participate in this study.
Boys: 5 years and older
Girls: 5 Years and older

Requirements
In addition to taking study medication at home, participants will receive physical exams by a doctor, blood draws, and pulmonary function tests during study visits.
Visits: 10
Duration: 12 months

Status: Open for Enrollment

How to Participate
To get started, please contact either:
Elizabeth Hartigan, RN
Sandy Hurban, RN
Adrienne Horn, RN
1-877-296-9026

Additional Resources
Cystic Fibrosis
Study Description at National Institutes of Health

Principal Investigator
Daniel Weiner, MD
Pulmonology Laboratory

Source of Support
Inspire Pharmaceuticals, Inc.