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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


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 Disease

Improvement in Appearance of Nasal Passages/Sinuses

Secondary outcome:

Chronic Sinusitis Survey Score

Pulmonary 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.


Minimum age: 5 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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