Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis
|ClinicalTrials.gov Identifier: NCT00416182|
Recruitment Status : Completed
First Posted : December 27, 2006
Results First Posted : November 14, 2014
Last Update Posted : November 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Sinusitis Cystic Fibrosis||Drug: Pulmozyme (dornase alfa) Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot Study|
|Study Start Date :||December 2006|
|Primary Completion Date :||June 2012|
|Study Completion Date :||June 2012|
U.S. FDA Resources
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
- Computed Tomography Evidence of Less Sinus Disease [ Time Frame: baseline and 1 year ]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 ]
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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|