Status:
COMPLETED
Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis
Lead Sponsor:
University of Vermont
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Sinusitis
Cystic Fibrosis
Eligibility:
All Genders
5+ years
Phase:
PHASE2
Brief 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 wit...
Detailed Description
AIM: To evaluate the effectiveness of Pulmozyme(dornase alfa) in decreasing post-operative sinusitis symptoms in patients with cystic fibrosis (CF) PROCEDURES: 20 patients with CF will be randomized ...
Eligibility Criteria
Inclusion
- 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
- Pregnancy
- Intolerance of orally inhaled Pulmozyme (dornase alfa)
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00416182
Start Date
December 1 2006
End Date
June 1 2012
Last Update
November 14 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401