Status:
COMPLETED
Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Lead Sponsor:
University of Jena
Collaborating Sponsors:
PD Dr. Joachim Riethmöller, Tübingen
PD Dr. Assen Koitschev, Tübingen
Conditions:
Cystic Fibrosis
Chronic Rhinosinusitis
Eligibility:
All Genders
5+ years
Phase:
PHASE3
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 Chlo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00265434
Start Date
December 1 2005
End Date
May 1 2006
Last Update
December 4 2014
Active Locations (1)
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1
Friedrich-Schiller-Universität
Jena, Thuringia, Germany, 07740