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
  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 2

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:


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:
    Drug: Tobramycin (Gernebcin®)
    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
Pseudomonas Infections
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Gram-Negative Bacterial Infections
Bacterial Infections
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014