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