Bramitob ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
299嚢胞性線維症14

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2014-001401-41-NL
(EUCTR)
29/07/201415/05/2014Once daily deep inhalation of tobramycin with smart nebulizer more effective to treat small airways disease in cystic fibrosis?Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis - TAPAS study in patients with CF Cystic Fibrosis and chronic infection with Pseudomonas aeruginosa;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Bramitob 300mg/4ml Nebuliser SolutionNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Netherlands
2EUCTR2013-004488-30-NL
(EUCTR)
31/01/201411/12/2013Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK)Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK) - TAPAS-PK study in patients with CF Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Bramitob
INN or Proposed INN: TOBRAMYCIN
Other descriptive name: TOBRAMYCIN
Haga HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
3EUCTR2012-002503-17-NL
(EUCTR)
21/12/201214/08/2012Tobramycin nebulisation with I-neb (TONI) study in children with cystic fibrosis: pharmacokinetics and safetyTobramycin nebulisation with I-neb (TONI) study in children with cystic fibrosis: pharmacokinetics and safety - TONI study in children with CF Cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Bramitob
Product Name: Bramitob
Product Code: 033841
INN or Proposed INN: TOBRAMYCIN
Erasmus University Medical CentreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
4EUCTR2011-006171-19-IT
(EUCTR)
27/10/201113/01/2012Multicentric and randomized study to evaluate the effectiveness of the association of the 2 different treatments in the early P.aerugionsa infection in patient with cystic fibrosis disease. The study will enlist pazients over 5 years old.randomized multicentric clinical trial upon efficacy of two different drugs combination to eradication of early p.aeruginosa infection in cystic fibrosis patients over 5 years old. Cystic fibrosis patients with early P.aeruginosa infection.
MedDRA version: 14.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: CIPROXIN*6CPR RIV 500MG
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Trade Name: BRAMITOB*NEBUL 56F 300MG/4ML
INN or Proposed INN: TOBRAMYCIN
Trade Name: CIPROXIN*6CPR RIV 500MG
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Trade Name: PROMIXIN*NEBUL 30MONOD 1MUI
INN or Proposed INN: COLISTIN MESILATE SODIUM
AZIENDA OSPEDALIERA MEYERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
5EUCTR2011-001821-26-IT
(EUCTR)
18/10/201120/03/2012Aerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosisAerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosis: pilot study of antimicrobial activity Adult patient with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: BRAMITOB*NEBUL 28F 300MG/4ML
INN or Proposed INN: TOBRAMYCIN
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANONULLNot RecruitingFemale: yes
Male: yes
Italy
6NCT01116089
(ClinicalTrials.gov)
July 201029/4/2010Pharmacokinetic Study of Bramitob® Administered for Inhalation by PARI eFlow® vs PARI LC® PLUS NebulizerPHARMACOKINETIC STUDY OF BRAMITOB® ADMINISTERED FOR INHALATION BY PARI eFLOW® RAPID ELECTRONIC NEBULIZER VS PARI LC® PLUS NEBULIZER COUPLED WITH THE PARI TURBO BOY® N COMPRESSOR IN CYSTIC FIBROSIS PATIENTS INFECTED WITH PSEUDOMONAS AERUGINOSACystic FibrosisDrug: Bramitob® administered by PARI LC® PLUS nebulizer;Drug: Bramitob® administered by PARI eFlow® rapid electronic nebulizerChiesi Farmaceutici S.p.A.NULLCompleted18 YearsN/AAll25Phase 1Czechia;Moldova, Republic of;Slovakia;Czech Republic;Russian Federation
7EUCTR2006-006215-68-FR
(EUCTR)
21/09/200906/08/2009A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
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: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Phase 3France;Hungary;Czech Republic;Spain;Germany
8NCT01111383
(ClinicalTrials.gov)
September 200913/4/2010A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®A Single Arm 48-Week Follow-on Safety Study to the Core Study (A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa)Cystic FibrosisDrug: tobramycinChiesi Farmaceutici S.p.A.NULLCompleted6 YearsN/AAll209Phase 3France;Poland;Ukraine
9NCT00885365
(ClinicalTrials.gov)
April 200920/4/2009A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas AeruginosaCystic FibrosisDrug: tobramycin / Bramitob;Drug: tobramycin / TOBIChiesi Farmaceutici S.p.A.NULLCompleted6 YearsN/AAll324Phase 3Czechia;France;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine;Czech Republic
10EUCTR2006-006215-68-ES
(EUCTR)
22/08/200827/06/2008ENSAYO 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 AERUGINOSAENSAYO 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.ANULLNot RecruitingFemale: yes
Male: yes
320Phase 3France;Hungary;Czech Republic;Spain;Germany
11EUCTR2006-006215-68-DE
(EUCTR)
14/08/200818/12/2008A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
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: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320France;Hungary;Czech Republic;Spain;Germany
12EUCTR2006-006215-68-HU
(EUCTR)
13/08/200825/06/2008A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
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: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Hungary;Germany;Czech Republic;France;Spain
13EUCTR2006-006215-68-CZ
(EUCTR)
29/07/200816/06/2008A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
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: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Phase 3France;Hungary;Czech Republic;Spain;Germany
14EUCTR2014-001401-41-IT
(EUCTR)
07/09/2021Targeting Antibiotics to Pseudomonas aeruginosa in Small airways study in patients with Cystic FibrosisTargeting Antibiotics to Pseudomonas aeruginosa in Small airways (TAPAS) study in patients with Cystic Fibrosis - TAPAS study in patients with CF Cystic Fibrosis and chronic infection with Pseudomonas aeuroginosa
MedDRA version: 22.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: BRAMITOB - 300 MG/4 ML SOLUZIONE DA NEBULIZZARE 56 CONTENITORI MONODOSE 4 ML
Product Name: Bramitob
INN or Proposed INN: TOBRAMICINA
ERASMUS UNIVERSITY MEDICAL CENTER ROTTERDAMNULLNAFemale: yes
Male: yes
26Phase 4Netherlands;Italy