Cystic Fibrosis with chronic rhinosinusitis
Conditions
Interventions
Trade Name: Pulmozyme
Product Name: Pulmozyme
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: Dornase alfa
Other descriptive name: recombiant human Desoxyribonuclease ( rhDNase)
Sponsors
University of Jena
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Variations in the Sino-nasal-outcome test SNOT-20 adapt CF primary nasal parameters: obstruction of nasal breathing, sneeze stimulus, permanent nose running, thick-mucous nasal discharge, earaches ;Secondary Objective: 1. Changes of the Sino-nasal-outcome test SNOT-20 adapt CF (secondary nasal parameter and general quality of life and total SNOT 20 adapt CF- score) 2. Changes of pathological alterations visible in MRT images of nose and paranasal sinuses (in selected patients) 3. Changes in the nasal lavage fluid (cytology, cytokines, DNA fragments, microbiology) and in the serological markers of inflammation (CrP, IgG, blood count) 4. Changes in rhinoscopic findings 5. Changes in rhinomanometric findings 6. Incidence of rhinosinusitic and pulmonary exacerbations during therapy 7. Need for decongestants or nasal lavage during treatment ;Primary end point(s): Comparison of nasal inhalation therapy: 4 weeks of pulmozyme versus 4 weeks NaCl 0,9% including a 4 weeks wash out period in between both periods. The trial will be performed as randomized double blind placebo controlled study including a cross over of verum (Pulmozyme) and placebo (NaCl 0,9%) Primary end points will be changes in quality of life score (SNOT-20 ad CF). | — |
Countries
Germany
Outcome results
None listed