Tobramicina (DrugBank: Tobramicina)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 299 | Cystic fibrosis | 5 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2015-003040-39-IT (EUCTR) | 14/09/2016 | 28/09/2018 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection - Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder i | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE Product Name: Tobramicina polvere inalatoria Product Code: TBM100 INN or Proposed INN: TOBRAMICINA Other descriptive name: TOBRAMICINA Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE Product Name: Tobramicina polvere inalatoria Product Code: TBM100 INN or Proposed INN: TOBRAMICINA Other descriptive name: TOBRAMICINA Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE Product Name: Tobramicina polvere inalatoria Product Code: TBM100 INN or Proposed INN: TOBRAMICINA Other descriptive name: TOBRAMICINA | NOVARTIS PHARMA SERVICES AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 2 | EUCTR2011-000441-20-ES (EUCTR) | 21/09/2011 | 11/11/2011 | ESTUDIO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA | ESTUDIO ALEATORIZADO, ABIERTO, CONTROLADO CON MEDICAMENTO ACTIVO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA - TR02-108 | Infección pulmonar con Pseudomonas aeruginosa/ colonización en pacientes con fibrosis quística MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Amikacina liposomal (Arikace?) INN or Proposed INN: Sulfato de amikacina Trade Name: TOBI 300mg/ 5ml solución para inhalación con nebulizador INN or Proposed INN: tobramicina | Insmed Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Australia;United Kingdom;Slovakia;Canada;Belgium;Denmark;Spain;United States;Greece;Poland | |||
| 3 | EUCTR2007-004277-26-ES (EUCTR) | 25/08/2008 | 24/01/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. Pacientes adultos y pediátricos con fibrosis quística (FQ) con infección pulmonar por Pseudomonas aeruginosa (PA). MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 4 | EUCTR2006-006215-68-ES (EUCTR) | 22/08/2008 | 27/06/2008 | ENSAYO CLÍNICO MULTICÉNTRICO, MULTINACIONAL, ABIERTO, ALEATORIZADO, CON GRUPOS PARALELOS DE TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMICINA SOLUCIÓN PARA NEBULIZACIÓN, 300 mg DOS VECES AL DÍA EN VIALES UNIDOSIS DE 4 ML) EN COMPARACIÓN CON TOBI® EN EL TRATAMIENTO DE PACIENTES CON FIBROSIS QUÍSTICA E INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA | ENSAYO CLÍNICO MULTICÉNTRICO, MULTINACIONAL, ABIERTO, ALEATORIZADO, CON GRUPOS PARALELOS DE TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMICINA SOLUCIÓN PARA NEBULIZACIÓN, 300 mg DOS VECES AL DÍA EN VIALES UNIDOSIS DE 4 ML) EN COMPARACIÓN CON TOBI® EN EL TRATAMIENTO DE PACIENTES CON FIBROSIS QUÍSTICA E INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA | Infección pulmonar crónica por P. aeruginosa en pacientes con fibrosis quística MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramicina Trade Name: Tobi 300mg/5ml Solución para inhalación por nebulizador. Product Name: Tobi INN or Proposed INN: tobramycin | Chiesi Farmaceutici S.p.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Hungary;Germany;Czech Republic;France;Spain | |||
| 5 | EUCTR2005-003772-37-ES (EUCTR) | 09/02/2006 | 20/01/2006 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects Estudio aleatorizado, abierto, multicéntrico, fase III para evaluar la seguridad de Tobramicina polvo inhalatorio comparado con TOBI en pacientes con fibrosis quística. | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects Estudio aleatorizado, abierto, multicéntrico, fase III para evaluar la seguridad de Tobramicina polvo inhalatorio comparado con TOBI en pacientes con fibrosis quística. | Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762 | Product Name: Tobramycin Inhalation Powder Product Code: TIP INN or Proposed INN: Tobramycin Trade Name: TOBI 300mg/5mL Nebuliser Solution Product Name: TOBI INN or Proposed INN: Tobramycin | Chiron Corporation Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Greece;Spain;Germany;Italy;United Kingdom |