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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016780-11 | EudraCT Number |
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The purpose of this study is to assess pharmacokinetic and safety comparability of Bramitob® when administered for inhalation by using PARI eFlow® rapid electronic nebulizer vs PARI LC® PLUS nebulizer in Cystic Fibrosis Patients infected with Pseudomonas Aeruginosa
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PARI LC® PLUS nebulizer | Active Comparator |
| |
| PARI eFlow® rapid electronic nebulizer | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bramitob® administered by PARI LC® PLUS nebulizer | Drug | (tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma tobramycin pharmacokinetic parameters (Cmax and AUC0-t) after twice daily inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer | on day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma tobramycin pharmacokinetic parameters (Cmax, tmax and AUC0-t) after inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer | on day 1 | |
| Sputum tobramycin pharmacokinetic parameters (Cmax, tmax and AUC0-t) after inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer |
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Main inclusion Criteria:
Main exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jozef Ružička, MD, PhD | Fakultná nemocnica s poliklinikou Bratislava, Slovakia | Principal Investigator |
| Andrej Somos, MD | University Hospital of L. Pasteur, Pneumonology Department, Rastislavova 43, 041 90, Kosice, Slovakia | Principal Investigator |
| Jana Skřičková, MD, PhD | University Hospital Brno Bohunice, Jihlavská 20, 625 00, Brno, Czech Republic | Principal Investigator |
| Eva Beresova, M.D | University hospital with Health Center, F.D. Roosevelta Banská Bystrica, L. Svoboda´s square 1, 975 17, Banská Bystrica, Slovakia | Principal Investigator |
| Svetlana Şciuca, M.D, PhD | SMSI Institude of Cardiology, MD-2025, 29/1 Testimitanu str., Chisinau, Republic of Moldova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Brno Bohunice | Brno | 625 00 | Czechia | |||
| SMSI Institude of Cardiology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23232039 | Result | Govoni M, Poli G, Acerbi D, Santoro D, Cicirello H, Annoni O, Ruzicka J. Pharmacokinetic and tolerability profiles of tobramycin nebuliser solution 300 mg/4 ml administered by PARI eFlow((R)) rapid and PARI LC Plus((R)) nebulisers in cystic fibrosis patients. Pulm Pharmacol Ther. 2013 Apr;26(2):249-55. doi: 10.1016/j.pupt.2012.12.002. Epub 2012 Dec 8. |
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|
| Bramitob® administered by PARI eFlow® rapid electronic nebulizer | Drug | (tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days |
|
|
| on day 1 and on day 28 |
| Accumulation of tobramycin in plasma and sputum after repeated doses calculated as the ratio: AUC0-t DAY 28 / AUC0-t DAY 1 and Cmax DAY 28 / Cmax DAY 1 | day 1 - day 28 |
| Safety assessed by adverse events, adverse drug reactions, incidence of bronchospasm, laboratory parameters, physical examination, body weight, vital signs results | day1-day28 |
| Number of patients with minimum plasma tobramycin levels Cmin > 2mcg/mL and maximum plasma tobramycin levels Cmax > 12 mcg/mL | on day 28 |
| Time necessary for the nebulization of the dose | on day 1 and on day 28 |
| Chisinau |
| MD-2025 |
| Moldova |
| University hospital with Health Center | Banská Bystrica | 975 17 | Slovakia |
| Fakultná nemocnica s poliklinikou Bratislava (FNsP) | Brastislava | 826 06 | Slovakia |
| University Hospital of L. Pasteur, Pneumonology Department | Košice | 041 90 | Slovakia |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D009330 | Nebulizers and Vaporizers |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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