Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization
NCT ID: NCT00774072
Last Updated: 2014-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
9 participants
INTERVENTIONAL
2008-10-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tobramycin 80 mg
applied once daily via Pari Sinus nebulizer
Tobramycin (Gernebcin®)
1 ml / day in each nostril
isotonic saline
applied once daily via Pari Sinus nebulizer
Tobramycin (Gernebcin®)
1 ml / day in each nostril
Interventions
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Tobramycin (Gernebcin®)
1 ml / day in each nostril
Eligibility Criteria
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Inclusion Criteria
* 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 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)
8 Years
ALL
No
Sponsors
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University of Jena
OTHER
Responsible Party
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PD Dr. Jochen G. Mainz
Head, CF Center
Principal Investigators
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Jochen Mainz, M.D.
Role: STUDY_CHAIR
University of Jena, Children's hospital
Locations
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Universitäts-Kinderklinik
Tübingen, Baden-Würtemberg, Germany
Mukoviszidosezentrum der Friedrich-Schiller-Universität
Jena, Thuringia, Germany
Countries
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References
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Mainz JG, Arnold C. Authors' reply. Drug Des Devel Ther. 2014;8:1136-7. No abstract available.
Mainz JG, Michl R, Pfister W, Beck JF. Cystic fibrosis upper airways primary colonization with Pseudomonas aeruginosa: eradicated by sinonasal antibiotic inhalation. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1089-90. doi: 10.1164/ajrccm.184.9.1089. No abstract available.
Mainz JG, Schadlich K, Schien C, Michl R, Schelhorn-Neise P, Koitschev A, Koitschev C, Keller PM, Riethmuller J, Wiedemann B, Beck JF. Sinonasal inhalation of tobramycin vibrating aerosol in cystic fibrosis patients with upper airway Pseudomonas aeruginosa colonization: results of a randomized, double-blind, placebo-controlled pilot study. Drug Des Devel Ther. 2014 Feb 10;8:209-17. doi: 10.2147/DDDT.S54064. eCollection 2014.
Other Identifiers
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tobra nasal CF pilot
Identifier Type: -
Identifier Source: org_study_id