Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot Study|
- Computed tomography evidence of less sinus disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]compare sinus CT pre-op to one year after initiation of study drug
- Improvement in appearance of nasal passages/sinuses [ Time Frame: 1 year ] [ Designated as safety issue: No ]periodic endoscopic photos of sinuses by ENT surgeon
- Sinusitis survey scores [ Time Frame: 1 year ] [ Designated as safety issue: No ]pre-surgery and end of trial (12 months)
- Number of antibiotic courses for sinusitis [ Time Frame: 1 year ] [ Designated as safety issue: No ]record number of courses of oral or IV antibiotics during the study
- Pulmonary function [ Time Frame: 1 year ] [ Designated as safety issue: No ]prior to surgery and end of study spirometry as measured by FEV1
|Study Start Date:||December 2006|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Drug: Pulmozyme (dornase alfa)
AIM: To evaluate the effectiveness of Pulmozyme(dornase alfa) in decreasing post-operative sinusitis symptoms in patients with cystic fibrosis
PROCEDURES: 20 patients with CF will be randomized to receive either Pulmozyme or placebo via nasal inhalation daily for 12 months. Consent will be obtained following surgery and treatment will begin 1 week post-operatively.
Monitoring will include examination and recording of adverse effects and follow up weekly for one month and then at 2.5, 6, 9 and 12 months.
Outcome measures will include ciliary function testing, pulmonary function testing, sinus questionnaires and CT scan.
|United States, Vermont|
|Fletcher Allen Health Care|
|Burlington, Vermont, United States, 05401|
|Principal Investigator:||Thomas Lahiri, MD||University of Vermont|
|Study Director:||Emily Keller||Fletcher Allen Health Care|