Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis
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||University of Vermont Medical Center|