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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 tobramycin

Tolerability

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

Page last updated: August 23, 2015

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