Tbm100    (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36

299. 嚢胞性線維症 [臨床試験数:1,592,薬物数:1,539(DrugBank:255),標的遺伝子数:81,標的パスウェイ数:162
Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
36 / 1,592 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-003040-39-DE
(EUCTR)
23/12/201611/10/2016Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa InfectionA 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 Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis
MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: Tobramycin inhalation powder
Product Code: TBM100
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland
2EUCTR2015-003040-39-ES
(EUCTR)
29/09/201630/08/2016Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa InfectionA 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 Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis
MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.0;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: Tobramycin inhalation powder
Product Code: TBM100
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland
3EUCTR2015-003040-39-IT
(EUCTR)
14/09/201628/09/2018Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa InfectionA 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 AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy
4EUCTR2012-001565-33-IE
(EUCTR)
08/01/201511/09/2014An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistinAn open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 17.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Colistimethate
Other descriptive name: COLISTIMETHATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
67Phase 4Spain;Ireland;Germany;United Kingdom;Switzerland
5EUCTR2014-001204-21-DE
(EUCTR)
17/11/201422/08/2014An open-label clinical trial that evaluates the lung clearance index in cystic fibrosis patients = 6 years of age, chronically infected with Pseudomonas aeruginosaAn 8 week open-label interventional multicenter study to evaluate the lung clearance index as endpoint for clinical trials in cystic fibrosis patients = 6 years of age, chronically infected with Pseudomonas aeruginosa Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Novartis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
Phase 4Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2012-001565-33-ES
(EUCTR)
04/07/201316/05/2013An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistinAn open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 16.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Trade Name: TOBI 300 mg/5 ml solución para inhalación por nebulizador
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Trade Name: Promixin,1 millón de Unidades Internacionales,polvo para solución para inhalación por nebulizador
INN or Proposed INN: Colistimethate
Other descriptive name: COLISTIMETHATE
Novartis Farmaceutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
67Phase 4Spain;Ireland;Germany;United Kingdom;Switzerland
7EUCTR2012-003532-23-DE
(EUCTR)
20/06/201305/02/2013An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 15.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 15.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
120Phase 4France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy
8EUCTR2012-001565-33-DE
(EUCTR)
05/06/201318/04/2013An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistinAn open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.1;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Colistimethate
Other descriptive name: COLISTIMETHATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
67Phase 4Spain;Ireland;Germany;United Kingdom;Switzerland
9NCT01775137
(ClinicalTrials.gov)
February 201322/1/2013Ext. Long-term Safety Study in CF Patients: Single Arm TIPA 48 Week Extension to CTBM100C2401, a Single Arm, Open-label, Multicenter, Phase IV Extension Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis Who Completed Participation in CTBM100C2401.Long-term Safety of TIPDrug: TBM100Novartis PharmaceuticalsNULLCompleted6 YearsN/AAll45Phase 4United States;Argentina;Australia;Canada;Germany;Hungary;Italy;Mexico;Spain
10EUCTR2012-003532-23-ES
(EUCTR)
29/01/201329/11/2012An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Farmaceutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
120Phase 4France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2012-003532-23-HU
(EUCTR)
19/12/201231/10/2012An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
120Phase 4France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy
12EUCTR2011-002000-32-IT
(EUCTR)
09/02/201206/03/2012A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA single arm, open-label, multicenter, Phase IV trial to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Tobramycin inhalation powder
Product Code: TBM100C
INN or Proposed INN: TOBRAMYCIN
Other descriptive name: NA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
150Phase 4United States;Hungary;Mexico;Canada;Argentina;Spain;Brazil;Australia;Germany;Italy
13NCT01519661
(ClinicalTrials.gov)
January 201224/1/2012Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic FibrosisA Single Arm, Open-label, Multicenter, Phase IV Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic FibrosisPulmonary Infections;Pseudomonas Aeruginosa in Cystic FibrosisDrug: TBM100Novartis PharmaceuticalsNULLCompleted6 YearsN/AAll157Phase 4United States;Argentina;Australia;Canada;France;Germany;Hungary;Italy;Mexico;Spain;Brazil
14EUCTR2011-002000-32-DE
(EUCTR)
13/12/201131/10/2011A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler 28 mg Hartkapseln mit Pulver zur Inhalation
Product Name: TOBI Podhaler 28 mg Hartkapseln mit Pulver zur Inhalation
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
150Phase 4France;United States;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy
15EUCTR2011-002000-32-HU
(EUCTR)
25/11/201105/09/2011A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler 28 mg inhalációs por, kemény kapszula
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
150Phase 4France;United States;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2011-002000-32-ES
(EUCTR)
17/11/201128/09/2011A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis - not available Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI PODHALER
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Farmaceutica S. ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Hungary;Germany;Canada;Mexico;Argentina;France;Spain;Italy;United States;Brazil;Australia
17EUCTR2005-003772-37-IE
(EUCTR)
26/07/201108/07/2008A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis
Classification code 10011762
Product Name: Tobramycin Inhalation Powder (TIP)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Trade Name: TOBI
Product Name: TOBI
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Greece;Spain;Ireland;Germany;Italy;United Kingdom
18EUCTR2009-016590-15-DE
(EUCTR)
19/07/201015/04/2010A clinical trial to assess the treatment with nebulised tobramycin in terms of safety and ability to kill Pseudomonas bacteria in the lungs of cystic fibrosis patients aged 3 months to 6 years includedA Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. Lung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: LLT;Classification code 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862
MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI 300 mg/5 ml Lösung für einen Vernebler
Product Name: TOBI
Product Code: TBM100
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
50France;Egypt;Hungary;Greece;Canada;Argentina;Poland;Romania;Russian Federation;Germany;Switzerland;Italy
19EUCTR2009-016734-26-BG
(EUCTR)
01/07/201015/06/2010A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Estonia;Lithuania;Bulgaria;Latvia
20EUCTR2009-016734-26-LT
(EUCTR)
23/03/201020/01/2010A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Estonia;Lithuania;Bulgaria;Latvia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2009-016734-26-LV
(EUCTR)
17/02/201011/01/2010A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
22EUCTR2009-016734-26-EE
(EUCTR)
08/01/201015/12/2009A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Estonia;Lithuania;Bulgaria;Latvia
23EUCTR2009-016590-15-HU
(EUCTR)
29/12/200925/11/2009A clinical trial to assess the treatment with nebulised tobramycin in terms of safety and ability to kill Pseudomonas bacteria in the lungs of cystic fibrosis patients aged 3 months to 6 years includedA Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. Lung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: LLT;Classification code 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862
MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI 300 mg / 5 mL nebuliser solution
Product Name: TOBI
Product Code: TBM100
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
50France;Hungary;Greece;Canada;Poland;Russian Federation;Germany;Italy;Switzerland
24EUCTR2008-002318-22-LT
(EUCTR)
07/09/200922/01/2009A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Other descriptive name: TBM100C
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
25EUCTR2008-004764-39-LT
(EUCTR)
07/09/200922/01/2009A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 13.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2008-002318-22-BG
(EUCTR)
20/08/200928/08/2009A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Estonia;Bulgaria;Latvia;Lithuania
27EUCTR2008-004764-39-BG
(EUCTR)
20/08/200928/08/2009A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 12.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Estonia;Bulgaria;Latvia;Lithuania
28EUCTR2008-004764-39-EE
(EUCTR)
30/07/200923/07/2009A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
29EUCTR2008-004764-39-LV
(EUCTR)
19/06/200908/05/2009A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
30EUCTR2008-002318-22-LV
(EUCTR)
13/05/200928/01/2009A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2008-002318-22-EE
(EUCTR)
06/05/200927/02/2009A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
32EUCTR2007-004507-36-DE
(EUCTR)
19/08/200819/10/2007A multicenter, open label, 2 period cross-over study to evaluate the Pharmacokinetics of an 8 week continuous treatment with 1x300mg/d and 2x300mg/d TOBI® inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) Subjects.A multicenter, open label, 2 period cross-over study to evaluate the Pharmacokinetics of an 8 week continuous treatment with 1x300mg/d and 2x300mg/d TOBI® inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) Subjects. patients with cystic fibrosis and chronical infection with Pseudomonas aeruginosa
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Tobi
Product Name: Tobi
Product Code: TBM100
INN or Proposed INN: Tobramycin
Trade Name: Tobi
Product Name: Tobi
Product Code: TBM100
INN or Proposed INN: Tobramycin
Trade Name: Tobi
Product Name: Tobi
Product Code: TBM100
INN or Proposed INN: Tobramycin
Trade Name: Tobi
Product Name: Tobi
Product Code: TBM100
INN or Proposed INN: Tobramycin
Novartis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
Germany
33EUCTR2005-003772-37-GR
(EUCTR)
03/06/200821/01/2008A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - ASPIRE IIA Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - ASPIRE II Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis
Classification code 10011762
Product Name: Tobramycin Inhalation Powder (TIP)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Trade Name: TOBI
Product Name: TOBI
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 3Hungary;Germany;United Kingdom;Spain;Italy;Greece
34EUCTR2005-003772-37-HU
(EUCTR)
08/11/200703/07/2007A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis
Classification code 10011762
Product Name: Tobramycin Inhalation Powder (TIP)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Trade Name: TOBI
Product Name: TOBI
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Germany;United Kingdom;Spain;Italy;Greece
35EUCTR2005-003772-37-GB
(EUCTR)
06/01/200609/11/2005A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis
Classification code 10011762
Product Name: Tobramycin Inhalation Powder (TIP)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Trade Name: TOBI
Product Name: TOBI
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Greece;Spain;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2011-002000-32-FR
(EUCTR)
22/09/2011A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
150Phase 4United States;France;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy