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

Primary Purpose

Cystic Fibrosis, Pseudomonas Aeruginosa

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Tobramycin (Gernebcin®)

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Universitäts-Kinderklinik
Mukoviszidosezentrum der Friedrich-Schiller-Universität

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tobramycin 80 mg

isotonic saline

Arm Description

applied once daily via Pari Sinus nebulizer

Outcomes

Primary Outcome Measures

Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid

Secondary Outcome Measures

Measure of serum levels of tobramycin

Tolerability

Full Information

NCT ID

NCT00774072

First Posted

October 16, 2008

Last Updated

December 3, 2014

Sponsor

University of Jena

1. Study Identification

Unique Protocol Identification Number

NCT00774072

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Jena

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis, Pseudomonas Aeruginosa

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tobramycin 80 mg

Arm Type

Active Comparator

Arm Description

applied once daily via Pari Sinus nebulizer

Arm Title

isotonic saline

Arm Type

Placebo Comparator

Arm Description

applied once daily via Pari Sinus nebulizer

Intervention Type

Drug

Intervention Name(s)

Tobramycin (Gernebcin®)

Intervention Description

1 ml / day in each nostril

Primary Outcome Measure Information:

Title

Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid

Time Frame

day -1, 1, 29, 30, 59, 60

Secondary Outcome Measure Information:

Title

Measure of serum levels of tobramycin

Time Frame

day 1, 30 and 60

Title

Tolerability

Time Frame

day 1, 30 and 60

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jochen Mainz, M.D.

Organizational Affiliation

University of Jena, Children's hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Universitäts-Kinderklinik

City

Tübingen

State/Province

Baden-Würtemberg

ZIP/Postal Code

72076

Country

Germany

Facility Name

Mukoviszidosezentrum der Friedrich-Schiller-Universität

City

Jena

State/Province

Thüringen

ZIP/Postal Code

07745

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

25199217

Citation

Mainz JG, Arnold C. Authors' reply. Drug Des Devel Ther. 2014;8:1136-7. No abstract available.

Results Reference

background

PubMed Identifier

22045752

Citation

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.

Results Reference

background

PubMed Identifier

24596456

Citation

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.

Results Reference

result

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

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