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CompletedNCT00774072Updated Dec 4, 2014

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

A Phase 2 interventional study of Tobramycin (Gernebcin®) in Cystic Fibrosis and Pseudomonas Aeruginosa, sponsored by University of Jena. Completed at 2 sites in Germany. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2014-12-04.

Sponsored by University of Jena · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
8 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cystic Fibrosis
  • Pseudomonas Aeruginosa

Keywords

  • subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways
03

In context

Pseudomonas Infections

97 studies on the registry are indexed under Pseudomonas Infections; 23 are open to participants now.

This study's enrollment of 9 is below the median of 56 across 60 interventional studies indexed under Pseudomonas Infections.

Browse Pseudomonas Infections studies →

Lead sponsor

University of Jena is the lead sponsor of 89 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years and older
Sexes eligible
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

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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
9 participants (actual)

Study arms

  • Active comparator
    Tobramycin 80 mg

    applied once daily via Pari Sinus nebulizer

    Drug: Tobramycin (Gernebcin®)

  • Placebo comparator
    isotonic saline

    applied once daily via Pari Sinus nebulizer

    Drug: Tobramycin (Gernebcin®)

Interventions

  • DrugTobramycin (Gernebcin®)

    1 ml / day in each nostril

06

What researchers measure

Primary outcomes

  1. Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid

    Time frame: day -1, 1, 29, 30, 59, 60

Secondary outcomes

  1. Measure of serum levels of tobramycin

    Time frame: day 1, 30 and 60

  2. Tolerability

    Time frame: day 1, 30 and 60

07

Study locations

2 sites
  • Universitäts-Kinderklinik
    Tübingen, Baden-Würtemberg 72076, Germany
  • Mukoviszidosezentrum der Friedrich-Schiller-Universität
    Jena, Thüringen 07745, Germany
08

References and documents

Publications

  • Mainz JG, Arnold C. Authors' reply. Drug Des Devel Ther. 2014;8:1136-7. No abstract available. PubMed 25199217 ↗
  • Mainz JG, Michl R, Pfister W, Beck JF. Cystic fibrosis upper airways primary colonization with Pseudomonas aeruginosa: eradicated by sinonasal antibiotic inhalation. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1089-90. doi: 10.1164/ajrccm.184.9.1089. No abstract available. PubMed 22045752 ↗
  • Mainz JG, Schadlich K, Schien C, Michl R, Schelhorn-Neise P, Koitschev A, Koitschev C, Keller PM, Riethmuller J, Wiedemann B, Beck JF. Sinonasal inhalation of tobramycin vibrating aerosol in cystic fibrosis patients with upper airway Pseudomonas aeruginosa colonization: results of a randomized, double-blind, placebo-controlled pilot study. Drug Des Devel Ther. 2014 Feb 10;8:209-17. doi: 10.2147/DDDT.S54064. eCollection 2014. PubMed 24596456 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00774072
Lead sponsor
University of Jena
Responsible party
PD Dr. Jochen G. Mainz (Head, CF Center, University of Jena) — Principal investigator
First posted
Oct 17, 2008
Start date
Oct 2008
Primary completion
Nov 2010
Completion
Nov 2010
Last update
Dec 4, 2014

Study contacts

Jochen Mainz, M.D.
study chair · University of Jena, Children's hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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