Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis - Full Text View

Sponsor:	University of Vermont
Collaborator:	Genentech
Information provided by (Responsible Party):	Thomas Lahiri, University of Vermont
ClinicalTrials.gov Identifier:	NCT00416182

Purpose

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.

Condition	Intervention	Phase
Sinusitis Cystic Fibrosis	Drug: Pulmozyme (dornase alfa)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group 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

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis Sinusitis

Drug Information available for: Dornase alfa

U.S. FDA Resources

Further study details as provided by University of Vermont:

Primary Outcome Measures:

Computed tomography evidence of less sinus disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
compare sinus CT pre-op to one year after initiation of study drug
Improvement in appearance of nasal passages/sinuses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
periodic endoscopic photos of sinuses by ENT surgeon

Secondary Outcome Measures:

Sinusitis survey scores [ Time Frame: 1 year ] [ Designated as safety issue: No ]
pre-surgery and end of trial (12 months)
Number of antibiotic courses for sinusitis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
record number of courses of oral or IV antibiotics during the study
Pulmonary function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
prior to surgery and end of study spirometry as measured by FEV1

Estimated Enrollment:	20
Study Start Date:	December 2006
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Intervention Details:

2.5 mg of dornas alfa or placebo delivered via Sinustar nasal nebulizer device

Detailed Description:

AIM: To evaluate the effectiveness of Pulmozyme(dornase alfa) in decreasing post-operative sinusitis symptoms in patients with cystic fibrosis

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

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical and laboratory diagnosis of cystic fibrosis
Age greater than or equal to 5 years
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416182

Locations

United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401

Sponsors and Collaborators

University of Vermont

Genentech

Investigators

Principal Investigator:	Thomas Lahiri, MD	University of Vermont
Study Director:	Emily Keller	Fletcher Allen Health Care

More Information

No publications provided

Responsible Party:	Thomas Lahiri, Associate Professor of Pediatrics, University of Vermont
ClinicalTrials.gov Identifier:	NCT00416182 History of Changes
Other Study ID Numbers:	Z3297S
Study First Received:	December 26, 2006
Last Updated:	September 28, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Vermont:

Cystic fibrosis
chronic sinusitis
mucolytic

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Sinusitis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases

Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on February 09, 2012