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Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis

NCT00416182 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-11-14

Study results available
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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.

Conditions

Interventions

DRUG

Pulmozyme (dornase alfa)

2.5 mg/2.5 mL of Pulmozyme (dornase alfa) delivered via Sinustar nasal nebulizer device

DRUG

Placebo

2.5 mL of placebo delivered via Sinustar nebulizer device

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • University of Vermont

    lead OTHER

Principal Investigators

  • Thomas Lahiri, MD · University of Vermont

  • Sandra Diehl, MS · University of Vermont Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00416182 on ClinicalTrials.gov