Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Jena
• Treatments: Tobramycin

Criteria

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)