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Nasal Inhalation of Pulmozyme in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

NCT00534079 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2014-12-04

No results posted yet for this study

Summary

Rhinosinusitis disorders are often associated with Cystic Fibrosis. They can restrict quality of life enormously and give cause to repeated ENT surgery. The basic defect in CF is a dysfunction of chloride channels in exocrine glands, leading to retention of secretions and consecutive chronic inflammation with bacterial superinfections.

The prospective placebo controlled cross-over study aims at the evaluation of a nasally inhalation of Pulmozyme with respect to mucus retention and resulting inflammation.

Conditions

Interventions

DRUG

Dornase alfa (Pulmozyme)

1 x 2,5 ml per day, inhalation use, for 28 days

DRUG

isotonic saline

1 x 2,5 ml per day, inhalation use, for 28 days

Sponsors & Collaborators

  • University of Jena

    lead OTHER

Principal Investigators

  • Jochen Mainz, M.D. · University of Jena

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • Germany

Study Locations

More Related Trials

Entities

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 NCT00534079 on ClinicalTrials.gov