drugset / Trial / NCT00265434
Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Phase 3
Completed
5 enrolled
University of Jena
Dr. Gerlind Schneider · collabPD Dr. Assen Koitschev, Tübingen · collabPD Dr. Joachim Riethmöller, Tübingen · collab
RandomizedCrossoverQuadruple-blindTreatment
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.
Timeline
- Start
- 2005-12
- Primary completion
- 2006-05
- Completion
- 2006-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | dornase alfa | Protein / enzyme biologic | — | Intranasal |