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

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Jena
• Collaborators: Dr. Gerlind Schneider; PD Dr. Assen Koitschev, Tübingen; PD Dr. Joachim Riethmöller, Tübingen

Criteria

Inclusion Criteria (most important):

• Subject has a confirmed diagnosis of cystic fibrosis.

• Subject has chronic or recurrent rhinosinusitic disorders.

• Subject is 5 years or older.

Exclusion Criteria (most important):

• Subject has a critical condition (FEV1<30% and SaO2<93%).

• Subject had an ENT surgery within 6 months prior to study.