asale Inhalation von Pulmozyme bei Patienten mit Mukoviszidose und chronischer Rhinosinusitis mit dem Pari Sinus-Vernebler.- bizentrische, randomisierte, doppel-blinde, placebo-kontrollierte, prospektive klinische Studie -Nasal Inhalation of Dornase alfa (Pulmozyme) in Patients with Cystic Fibrosis and Chronic Rhinosinusitis - pulmozyme-nasal-cf

Phase 1

Conditions: Cystic Fibrosis with chronic rhinosinusitis

Registration Number: EUCTR2007-001548-36-DE

Lead Sponsor: niversity of Jena

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 16

Inclusion Criteria

1. Subject has a confirmed diagnosis of cystic fibrosis based on:
3 positive sweat chloride tests and/or genetic characterisation.
2. Subject is 5 years of age or older.
3. Subject has chronic or recurrent rhinosinusitic disorders.
4. Subject is able to comply with the Inhalation procedures scheduled in the protocol.
5. Subject is able to comply with the nasal lavage procedures scheduled in the protocol.
6. Therapy is completely possible without any restrictions.
5. Women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol (e.g. implants, combined oral contraceptives, injectables, some IUDs, sexual abstinence or vasectomised partner).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject has a critical condition defined as:
FEV1 < 30% and / or
SaO2 < 93% without O2-substitution; need of O2-substitution
2. Subject had an ENT surgery within 6 months prior to study
3. Subject shows signs of nasal bleeding
4. Subject has an ear drum perforation
5. Subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy
6. Subject has a new therapy with nasal topic steroids during treatment interval
7. Subject has a new systemic steroid therapy
8. Subject is unlikely to comply with the procedures scheduled in the protocol
9. Subject has a known allergic reaction to the medication
10. Subject is pregnant or breastfeeding
11.Patient participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study.