Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis
Information source: University of Vermont
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sinusitis; Cystic Fibrosis
Intervention: Pulmozyme (dornase alfa) (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Vermont Official(s) and/or principal investigator(s): Thomas Lahiri, MD, Principal Investigator, Affiliation: University of Vermont Sandra Diehl, MS, Study Director, Affiliation: University of Vermont Medical Center
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 with cystic fibrosis who have recently undergone sinus surgery.
Clinical Details
Official title: The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Computed Tomography Evidence of Less Sinus DiseaseImprovement in Appearance of Nasal Passages/Sinuses
Secondary outcome: Chronic Sinusitis Survey ScorePulmonary Function
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 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.
Eligibility
Minimum age: 5 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- Pregnancy
- Intolerance of orally inhaled Pulmozyme (dornase alfa)
Locations and Contacts
Fletcher Allen Health Care, Burlington, Vermont 05401, United States
Additional Information
Starting date: December 2006
Last updated: November 12, 2014
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