NCT00534079

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

Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis - a Double Blind Placebo-controlled Cross-over, Bicenter, Prospective Clinical Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Jena · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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

• Cystic Fibrosis
• Rhinosinusitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2007-09-24
• Last updated: 2014-12-04

Locations

2 sites across 1 country: Germany