Status:
COMPLETED
Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization
Lead Sponsor:
University of Jena
Conditions:
Cystic Fibrosis
Pseudomonas Aeruginosa
Eligibility:
All Genders
8+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00774072
Start Date
October 1 2008
End Date
November 1 2010
Last Update
December 4 2014
Active Locations (2)
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1
Universitäts-Kinderklinik
Tübingen, Baden-Würtemberg, Germany, 72076
2
Mukoviszidosezentrum der Friedrich-Schiller-Universität
Jena, Thuringia, Germany, 07745