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.
Drug: Pulmozyme (dornase alfa)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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: baseline and 1 year ] [ Designated as safety issue: No ]compare sinus CT pre-op (baseline) to one year after initiation of study drug Difference in pre and post scores by Lund-McKay scoring system are reported (1 year minus baseline) The Lund-Mackay scoring system was used to evaluate the extent and severity of sinusitis. The scale ranges from 0 (best possible outcome with complete lucency of all sinuses) to 24 (worst possible outcome with complete opacification of all sinuses)
- Improvement in Appearance of Nasal Passages/Sinuses [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
periodic endoscopic photos of sinuses by ear-nose-throat (ENT) surgeon. The scale for scoring severity of disease ranges from 0 (best possible outcome) to 2 (worst possible outcome).
independent blinded scoring by 2 surgeons difference in scores pre and post are reported (1 year minus baseline)
- Chronic Sinusitis Survey Score [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]pre-surgery and end of trial (12 months) Reduction in scores (baseline minus 1 year) are recorded The chronic sinusitis survey consists of 6 questions, ranges from 0-24, a lower score indicates the best possible outcome.
- Pulmonary Function [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]prior to surgery and end of study spirometry as measured by forced expiratory volume in 1 second (FEV1) percent predicted. The change over the course of the study (1 year minus baseline) is reported. A higher value indicates a better outcome.
|Study Start Date:||December 2006|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
2.5 mg Pulmozyme (dornase alfa) delivered intranasally once daily
Drug: Pulmozyme (dornase alfa)
2.5 mg/2.5 mL of Pulmozyme (dornase alfa) delivered via Sinustar nasal nebulizer device
Other Name: Pulmozyme, dornase alfa, human recombinant DNase 1
Placebo Comparator: placebo
2.5 mg/2mL placebo administered intranasally once daily
2.5 mL of placebo delivered via Sinustar nebulizer device
Other Name: placebo comparator
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416182
|United States, Vermont|
|Fletcher Allen Health Care|
|Burlington, Vermont, United States, 05401|
|Principal Investigator:||Thomas Lahiri, MD||University of Vermont|
|Study Director:||Sandra Diehl, MS||Fletcher Allen Health Care|