NCT00659529

Safety and Efficacy of Sildenafil in Cystic Fibrosis (CF) Lung Disease

The Role of Phosphodiesterase Inhibitors in CF Lung Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: National Jewish Health · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether sildenafil can decrease inflammation in CF lung disease.

Detailed description

This study is an open-label study that examines the use of sildenafil (Revatio) in clinically stable patients with mild to moderate CF lung disease. The length of participation for each subject will be approximately 10 weeks, and will consist of a screening visit, a study visit for initiation of study drug if subject qualifies, interim visits to escalate drug dose, obtain drug levels, review concomitant medications and assess side effects, a visit at the end of the therapy period (to reassess inflammatory markers, laboratory studies and side effects,) and a follow-up assessment 2 weeks after subject completion.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	sildenafil	Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks.

Timeline

• Start date: 2008-08-01
• Primary completion: 2012-08-01
• Completion: 2012-12-01
• First posted: 2008-04-16
• Last updated: 2020-10-19
• Results posted: 2014-05-02

Locations

1 site across 1 country: United States