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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00774072
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : December 4, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Pseudomonas Aeruginosa Drug: Tobramycin (Gernebcin®) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2008
Primary Completion Date : November 2010
Study Completion Date : November 2010

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Tobramycin 80 mg
applied once daily via Pari Sinus nebulizer
Drug: Tobramycin (Gernebcin®)
1 ml / day in each nostril
Placebo Comparator: isotonic saline
applied once daily via Pari Sinus nebulizer
Drug: Tobramycin (Gernebcin®)
1 ml / day in each nostril

Outcome Measures

Primary Outcome Measures :
  1. Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid [ Time Frame: day -1, 1, 29, 30, 59, 60 ]

Secondary Outcome Measures :
  1. Measure of serum levels of tobramycin [ Time Frame: day 1, 30 and 60 ]
  2. Tolerability [ Time Frame: day 1, 30 and 60 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00774072

Tübingen, Baden-Würtemberg, Germany, 72076
Mukoviszidosezentrum der Friedrich-Schiller-Universität
Jena, Thüringen, Germany, 07745
Sponsors and Collaborators
University of Jena
Study Chair: Jochen Mainz, M.D. University of Jena, Children`s hospital
More Information

Responsible Party: PD Dr. Jochen G. Mainz, Head, CF Center, University of Jena
ClinicalTrials.gov Identifier: NCT00774072     History of Changes
Other Study ID Numbers: tobra nasal CF pilot
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by PD Dr. Jochen G. Mainz, University of Jena:
subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways

Additional relevant MeSH terms:
Cystic Fibrosis
Pseudomonas Infections
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents