Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization
Study Details
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 |
|---|---|---|
|
Phase 2 |
Study Design
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
- Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid [day -1, 1, 29, 30, 59, 60]
Secondary Outcome Measures
- Measure of serum levels of tobramycin [day 1, 30 and 60]
- Tolerability [day 1, 30 and 60]
Eligibility Criteria
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.
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitäts-Kinderklinik | Tübingen | Baden-Würtemberg | Germany | 72076 |
| 2 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- Mainz JG, Arnold C. Authors' reply. Drug Des Devel Ther. 2014;8:1136-7.
- 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.
- tobra nasal CF pilot