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

This study has been completed.

Sponsor:

Information provided by:

University of Jena

ClinicalTrials.gov Identifier:

NCT00774072

First received: October 16, 2008

Last updated: December 7, 2010

Last verified: December 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

October 16, 2008

Last Updated Date

December 7, 2010

Start Date ^ICMJE

October 2008

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid [ Time Frame: day -1, 1, 29, 30, 59, 60 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00774072 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Measure of serum levels of tobramycin [ Time Frame: day 1, 30 and 60 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Nasal Inhalation of Tobramycin by the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization in the Upper Airways

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Cystic Fibrosis
Pseudomonas Aeruginosa

Intervention ^ICMJE

Drug: Tobramycin (Gernebcin®)

1 ml / day in each nostril

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

8 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00774072

Other Study ID Numbers ^ICMJE

tobra nasal CF pilot

Has Data Monitoring Committee

Responsible Party

Dr. Jochen Mainz, University of Jena, Children`s hospital

Study Sponsor ^ICMJE

University of Jena

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Jochen Mainz, M.D.

University of Jena, Children`s hospital

Information Provided By

University of Jena

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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