Tbm100c    (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27

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.
27 / 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
1EUCTR2012-001565-33-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
2EUCTR2014-001204-21-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
3EUCTR2012-001565-33-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
4EUCTR2012-003532-23-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
5EUCTR2012-001565-33-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2012-003532-23-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
7EUCTR2012-003532-23-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
8EUCTR2011-002000-32-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
9EUCTR2011-002000-32-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
10EUCTR2011-002000-32-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
11EUCTR2011-002000-32-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
12EUCTR2005-003772-37-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
13EUCTR2009-016734-26-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
14EUCTR2009-016734-26-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
15EUCTR2009-016734-26-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2009-016734-26-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
17EUCTR2008-002318-22-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
18EUCTR2008-004764-39-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
19EUCTR2008-002318-22-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
20EUCTR2008-004764-39-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2008-004764-39-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
22EUCTR2008-004764-39-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
23EUCTR2008-002318-22-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
24EUCTR2008-002318-22-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
25EUCTR2005-003772-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2005-003772-37-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
27EUCTR2005-003772-37-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