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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bacterial Infections
Digestive System Diseases
Genetic Diseases, Inborn
Gram-Negative Bacterial Infections
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014