subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways
Conditions
Interventions
Trade Name: Gernebcin 80 mg
Product Name: Gernebcin 80 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: tobramycin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration ty
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. detection of P. aeruginosa in nasal lavage (culture) with chronic P. aeruginosa colonization of the lung (from day – 28) 3. informed consent of the patients or parents 4. Subject is older than 7 years 5. Subject is able to comply with the inhalation procedures and nasal lavage procedures scheduled in the protocol. 6. 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 3 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 against pseudomonas aerug. 6. Subject is unlikely to comply with the procedures scheduled in the protocol 7. Subject has a known allergic reaction to the medication 8. Subject is pregnant or breastfeeding 9. Subject participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study. 10. Systemic (oral or intravenous) antibiotic treatment against P.a. 14 days prior to the inclusion and during the study 11. If serum level of tobramycin is above 2 mg/l one hour after inhalation, subject has to withdraw the participation in the study. 12. progressed renal insufficiency 13. severe damage of the N. acusticus 14. dissiness (potential damage of N. vestibularis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid;Secondary Objective: 1. drug safety of nasal Tobramycin (only for pilot-study) - Serum levels in non-toxic range - mucosal tolerance 2. Changes of the Sino-nasal-outcome test SNOT-20 adapt CF / patient`s diary 3. detection of P. aeruginosa in sputum / througt swap 4. Genotyping of P. aeruginosa 5. Changes in rhinoscopic findings (size of polyps, mucosa, secretions) 6. Changes in rhinomanometric findings (pilot study) 7. Cytology, Cytokines in nasal lavage 8. Incidence of rhinosinusitic and pulmonal exazerbations;Primary end point(s): Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid | — |
Countries
Germany
Outcome results
None listed