Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Vermont.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Thomas Lahiri, University of Vermont
ClinicalTrials.gov Identifier:
NCT00416182
First received: December 26, 2006
Last updated: September 28, 2011
Last verified: September 2011
  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 2

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:


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:
    Drug: Pulmozyme (dornase alfa)
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Inc.
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:
Sinusitis
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014