Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization - Full Text View

Sponsor:	University of Jena
Information provided by:	University of Jena
ClinicalTrials.gov Identifier:	NCT00774072

Purpose

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.

Condition	Intervention	Phase
Cystic Fibrosis Pseudomonas Aeruginosa	Drug: Tobramycin (Gernebcin®)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Nasal Inhalation of Tobramycin by the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization in the Upper Airways

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Tobramycin Tobramycin sulfate

U.S. FDA Resources

Further study details as provided by University of Jena:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Enrollment:	9
Study Start Date:	October 2008
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Intervention Details:

1 ml / day in each nostril

Eligibility

Ages Eligible for Study:	8 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774072

Locations

Germany
Universitäts-Kinderklinik
Tübingen, Baden-Würtemberg, Germany, 72076
Mukoviszidosezentrum der Friedrich-Schiller-Universität
Jena, Thüringen, Germany, 07745

Sponsors and Collaborators

University of Jena

Investigators

Study Chair:

Jochen Mainz, M.D.

University of Jena, Children`s hospital

More Information

No publications provided

Responsible Party:	Dr. Jochen Mainz, University of Jena, Children`s hospital
ClinicalTrials.gov Identifier:	NCT00774072 History of Changes
Other Study ID Numbers:	tobra nasal CF pilot
Study First Received:	October 16, 2008
Last Updated:	December 7, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Jena:

subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn

Infant, Newborn, Diseases
Pathologic Processes
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012