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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tobramycin 80 mg | Active Comparator | applied once daily via Pari Sinus nebulizer |
|
| isotonic saline | Placebo Comparator | applied once daily via Pari Sinus nebulizer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobramycin (Gernebcin®) | Drug | 1 ml / day in each nostril |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid | day -1, 1, 29, 30, 59, 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of serum levels of tobramycin | day 1, 30 and 60 | |
| Tolerability | day 1, 30 and 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jochen Mainz, M.D. | University of Jena, Children's hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäts-Kinderklinik | Tübingen | Baden-Würtemberg | 72076 | Germany | ||
| Mukoviszidosezentrum der Friedrich-Schiller-Universität |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25199217 | Background | Mainz JG, Arnold C. Authors' reply. Drug Des Devel Ther. 2014;8:1136-7. No abstract available. | |
| 22045752 | Background | 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. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D011552 | Pseudomonas Infections |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014031 | Tobramycin |
| ID | Term |
|---|---|
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 |
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| Jena |
| Thuringia |
| 07745 |
| Germany |
| 24596456 | Result | 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. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| Carbohydrates |