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®)
Sponsored by
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
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
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
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
No
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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