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Clinical Trials/NCT00265434
NCT00265434
Completed
Phase 3

Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

University of Jena1 site in 1 country5 target enrollmentDecember 2005

Overview

Phase
Phase 3
Intervention
Pulmozyme
Conditions
Cystic Fibrosis
Sponsor
University of Jena
Enrollment
5
Locations
1
Primary Endpoint
Changes in sinonasal symptoms (SNOT-20
Status
Completed
Last Updated
11 years ago

Overview

Brief 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 the efficacy of a nasally inhalation of Pulmozyme with respect to mucus retention and resulting inflammation.

Registry
clinicaltrials.gov
Start Date
December 2005
End Date
May 2006
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
University of Jena
Responsible Party
Principal Investigator
Principal Investigator

PD Dr. Jochen G. Mainz

Head of CF Center, Pediatric Pulmonology

University of Jena

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Dornase alfa

DBPC-cross over trial

Intervention: Pulmozyme

isotonic saline

Intervention: Pulmozyme

Outcomes

Primary Outcomes

Changes in sinonasal symptoms (SNOT-20

Time Frame: 2 yrs

Study Sites (1)

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