Tobramycin Inhalation Powder (TIP) ( DrugBank: Tobramycin )


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21

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
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PhaseCountries
1NCT02212587
(ClinicalTrials.gov)
September 20146/8/2014Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia ComplexPilot Study of the in Vivo Efficacy of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia ComplexCystic Fibrosis;Burkholderia Cepacia InfectionDrug: TOBISt. Michael's Hospital, TorontoNULLCompleted6 YearsN/AAll10Phase 1Canada
2NCT02015663
(ClinicalTrials.gov)
January 201413/12/2013Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off CyclesA 24-week, Open-label, Parallel-group, Interventional Phase IV Study Comparing Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles for the Treatment of Pulmonary Pseudomonas Aeruginosa in Patients With Cystic FibrosisCystic FibrosisDrug: Tobramycin Inhalation PowderNovartis PharmaceuticalsNULLTerminated6 YearsN/AAll32Phase 4United States
3NCT01844778
(ClinicalTrials.gov)
August 201329/4/2013Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI)An Open-label, Crossover, Interventional Phase IV Study to Compare the Ease of Use of TIP With Nebulized TIS and Nebulized COLI for the Treatment of Pulmonary Pseudomonas Aeruginosa (P.a) in Patients With Cystic FibrosisCystic FibrosisDrug: Tobramycin Inhalation Powder;Drug: Tobramycin inhalation solution;Drug: ColistimethateNovartis PharmaceuticalsNULLCompleted6 YearsN/AAll60Phase 4Germany;Ireland;Spain;Switzerland;United Kingdom
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
5NCT01775137
(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
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-IT
(EUCTR)
18/01/201321/12/2012An 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 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Classification code 10011762;Term: Cystic fibrosis;Level: HLT;Classification code 10037132;Term: Pseudomonal infections;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI PODHALER*448CPS 28MG+10IN
INN or Proposed INN: Tobramycin
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
120Phase 4United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy
8EUCTR2012-003532-23-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
9NCT01519661
(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
10EUCTR2011-002000-32-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
11EUCTR2011-002000-32-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
12EUCTR2011-002000-32-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. ANULLNot RecruitingFemale: yes
Male: yes
150Phase 4United States;France;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy
13EUCTR2005-003772-37-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
14EUCTR2005-003772-37-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 AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Greece;Spain;Ireland;Germany;Italy;United Kingdom
15EUCTR2005-003772-37-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
16NCT00388505
(ClinicalTrials.gov)
February 200616/10/2006Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic FibrosisA Randomized, Open-label Multicentre Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to Tobramycin Solution for Inhalation in Cystic Fibrosis SubjectsCystic FibrosisDrug: Tobramycin Inhalation Powder;Drug: Tobramycin Solution for InhalationNovartis PharmaceuticalsNULLCompleted6 YearsN/AAll517Phase 3United States;Australia;Canada;Chile;Colombia;France;Germany;Hungary;Israel;Italy;Mexico;Netherlands;Spain;United Kingdom
17EUCTR2005-003772-37-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
18EUCTR2005-002035-28-LT
(EUCTR)
19/09/200524/08/2005A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) SubjectsA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects pulmonary P aeruginosa infection in patient with cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Tobramycin Inhalation Powder
Product Code: TIP
INN or Proposed INN: Tobramycine
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
220Phase 3Lithuania
19NCT00125346
(ClinicalTrials.gov)
September 200528/7/2005Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis SubjectsA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) SubjectsCystic FibrosisDrug: Tobramycin Inhalation PowderNovartisNULLTerminated6 Years21 YearsBoth98Phase 3United States;Argentina;Brazil;Bulgaria;Canada;Chile;Lithuania;Mexico;Former Serbia and Montenegro
20EUCTR2016-004318-82-Outside-EU/EEA
(EUCTR)
15/05/2017A study comparing Tobramycin Inhalation Powder (TIP) administered once daily continuously versus TIP administered BID in 28 day on / 28 day off cycles for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosisTobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: TOBI Podhaler
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Novartis Pharmaceuticals CorporationNULLNAFemale: yes
Male: yes
200Phase 4United States
21EUCTR2011-002000-32-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