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| Name | Class |
|---|---|
| University of Lyon | OTHER |
| Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME) | UNKNOWN |
| Clininfo S.A. | INDUSTRY |
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Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly related to the respiratory affection which appears early in neonates.
The constant improvement in symptomatic treatments and care strategies allowed CF patients' life expectancy to be increased over the last decades.
Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18 years old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.
Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is obtained by inhaled administration of tobramycin and is active against in-vitro resistant Pseudomonas aeruginosa.
Study hypotheses :
Regarding literature data and in-vitro studies, the administration of Nebcinal® 150mg/3ml administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus® in children and adult patients with CF.
Primary objective :
To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Other | experimental treatment (Nebcinal/Aeroneb Idehaler pocket) - 6day-wash out period - standard treatment (Tobi/Pari LC Plus) |
|
| Arm B | Other | standard treatment (Tobi/Pari LC Plus) - 6day-wash out period - experimental treatment (Nebcinal/Aeroneb Idehaler) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobramycin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of tobramycin from 0 to 8h after administration | from 0 to 8h after administration |
| Measure | Description | Time Frame |
|---|---|---|
| sputum of tobramycin concentrations | from 0 to 8 hours after administration | |
| Safety of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®; | 15 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Behrouz Kassaï | Contact | 04 27857732 | 0033 | |
| Jean-Paul Salin | Contact | 0140899260 | 0033 |
| Name | Affiliation | Role |
|---|---|---|
| Gabriel Bellon | Centre de Resources et de competences pour la mucovisidose | Principal Investigator |
| Isabelle Durieu, Pr | Centre de Resources et de competences pour la mucovisidose Hôpital Lyon Sud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Ressource et de Compétence Mucoviscidose Pédiatrique Centre de Référence Mucoviscidose | Recruiting | Lyon | 69500 | France |
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| Hospices Civils de Lyon |
| OTHER |
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| Time of nebulization of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket® |
| during nebulization |
| Satisfaction of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket® | after administration of the drug, in average 20 minutes |
| behrouz Kassai, Dr | University of Lyon | Study Chair |
| 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 |
|---|---|
| D014031 | Tobramycin |
| ID | Term |
|---|---|
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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