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

Phase 3

Completed

• Conditions: Cystic Fibrosis; Chronic Rhinosinusitis
• Interventions: Drug: Pulmozyme

• Registration Number: NCT00265434
• Lead Sponsor: University of Jena

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-13
• Study First Submitted QC: 2005-12-13
• Study First Posted: 2005-12-14
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-03
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
isotonic saline	Pulmozyme	-
Dornase alfa	Pulmozyme	DBPC-cross over trial

Primary Outcome Measures

Name	Time	Method
Changes in sinonasal symptoms (SNOT-20	2 yrs

Trial Locations

Locations (1)

Friedrich-Schiller-Universität; 🇩🇪 Jena, Thüringen, Germany