Cystic Fibrosis, Pseudomonas Aeruginosa
Conditions
Keywords
subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways
Brief summary
The purpose of this study is to determine whether the nasal inhalation of Gernebcin® is effective to decrease the Pseudomonas aeruginosa bacterial count in the nasal lavage fluid.
Interventions
DRUGTobramycin (Gernebcin®)
1 ml / day in each nostril
Sponsors
University of Jena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* subject has a confirmed diagnosis of cystic fibrosis * detection of P. aeruginosa in nasal lavage (culture) with chronic P.a. colonization of the lung (from day -28) * informed consent of the patients or parents * subject is older than 7 years * subject is able to comply with the inhalation procedures and nasal lavage procedures scheduled in the protocol * women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol
Exclusion criteria
* subject has a critical condition defined as: FEV1 \< 30% and / or SaO2 \< 93% without O2-substitution; need of O2-substitution * subject had an ENT surgery within 3 months prior to study * subject shows signs of nasal bleeding * subject has an ear drum perforation * subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy against pseudomonas aerug. * subject is unlikely to comply with the procedures scheduled in the protocol * subject has a known allergic reaction to the medication * subject is pregnant or breastfeeding * subject participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study. * systemic (oral or intravenous) antibiotic treatment against P.a. 14 days prior to the inclusion and during the study * if serum level of tobramycin is above 2 mg/l one hour after inhalation, subject has to withdraw the participation in the study. * progressed renal insufficiency * severe damage of the N. acusticus * dizziness (potential damage of. N. vestibularis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid | day -1, 1, 29, 30, 59, 60 |
Secondary
| Measure | Time frame |
|---|---|
| Measure of serum levels of tobramycin | day 1, 30 and 60 |
| Tolerability | day 1, 30 and 60 |
Countries
Germany
Outcome results
None listed