Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization
Information source: University of Jena
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis; Pseudomonas Aeruginosa
Intervention: Tobramycin (Gernebcin®) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Jena Official(s) and/or principal investigator(s): Jochen Mainz, M.D., Study Chair, Affiliation: University of Jena, Children`s hospital
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.
Clinical Details
Official title: Nasal Inhalation of Tobramycin by the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization in the Upper Airways
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid
Secondary outcome: Measure of serum levels of tobramycinTolerability
Eligibility
Minimum age: 8 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Universitäts-Kinderklinik, Tübingen, Baden-Würtemberg 72076, Germany
Mukoviszidosezentrum der Friedrich-Schiller-Universität, Jena, Thüringen 07745, Germany
Additional Information
Related publications: Mainz JG, Arnold C. Authors’ reply. Drug Des Devel Ther. 2014;8:1136-7. 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.
Starting date: October 2008
Last updated: December 3, 2014
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