Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic sinusitis is a frequent complication in cystic fibrosis. The aim of this study is to determine whether Pulmozyme(dornase alfa) would maintain sinus health (compared to placebo) in patients with cystic fibrosis who have recently undergone sinus surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Vermont
• Collaborator: Genentech, Inc.

Criteria

Inclusion Criteria:

• Clinical and laboratory diagnosis of cystic fibrosis

• Age greater than or equal to 5 years

• Forced expiratory volume in 1 second (FEV1) greater than or equal to 40% predicted

• Sinus surgery within one week of enrollment

Exclusion Criteria:

• Pregnancy

• Intolerance of orally inhaled Pulmozyme (dornase alfa)