Tad ( 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10

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
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agemin
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agemax
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gender
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size
PhaseCountries
1EUCTR2015-002743-33-NL
(EUCTR)
14/12/201818/07/2018A clinical trial to investigate the efficacy and safety of inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;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: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Zambon S.p.A.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Netherlands;Germany;New Zealand
2EUCTR2015-002743-33-GR
(EUCTR)
27/11/201814/11/2018A clinical trial to investigate the efficacy and safety of inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;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: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Zambon S.p.A.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3New Zealand;Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands
3EUCTR2015-002743-33-PT
(EUCTR)
13/07/201710/07/2017A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;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: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;New Zealand
4EUCTR2015-002743-33-DE
(EUCTR)
29/05/201701/03/2017A clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;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: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;New Zealand
5EUCTR2015-002743-33-ES
(EUCTR)
13/03/201710/02/2017A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 19.1;Level: PT;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: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
264Phase 3Portugal;Belgium;Spain;Germany;Italy;United Kingdom
6EUCTR2015-002743-33-IT
(EUCTR)
02/03/201725/01/2021A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - Promis 1 Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;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: Promixin/Tadim
Product Name: Colistimethate sodium
Product Code: [-]
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: -
Trade Name: Ventolin¿ Evohaler¿
Product Name: Ventolin
Product Code: [Ventolin]
INN or Proposed INN: SALBUTAMOL
Other descriptive name: Ventolin® Evohaler
ZAMBON SPANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;New Zealand
7EUCTR2015-002743-33-GB
(EUCTR)
21/02/201713/12/2016A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;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: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;United Kingdom;Italy;Switzerland;France;Belgium;Australia;Germany;Netherlands;New Zealand
8EUCTR2013-005481-19-DK
(EUCTR)
27/05/201427/05/2014High Dose Antioxidant Treatment for Patients with Cystic FibrosisHigh Dose Antioxidant Treatment for Patients with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 17.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Mucolysin
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: ACETYLCYSTEINE
Trade Name: Mucomyst
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: ACETYLCYSTEINE
Trade Name: ACC
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: ACETYLCYSTEINE
Trade Name: Tad
INN or Proposed INN: GLUTATHIONE
Other descriptive name: GLUTATHIONE SODIUM
Aarhus University HospitalNULLNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
9EUCTR2008-005080-33-IT
(EUCTR)
05/02/200919/01/2009RANDOMIZED, SINGLE BLIND, CONTROLLED TRIAL OF INHALED GLUTATHIONE VERSUS PLACEBO IN PATIENTS WITH CYSTIC FIBROSIS. - INHALED GSH VS PLACEBO IN CYSTIC FIBROSISRANDOMIZED, SINGLE BLIND, CONTROLLED TRIAL OF INHALED GLUTATHIONE VERSUS PLACEBO IN PATIENTS WITH CYSTIC FIBROSIS. - INHALED GSH VS PLACEBO IN CYSTIC FIBROSIS Cystic fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: TAD 600
INN or Proposed INN: Glutathione
AZIENDA OSPEDALIERA VINCENZO MONALDI DI NAPOLINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
10EUCTR2005-003870-88-DE
(EUCTR)
20/10/200628/08/2006Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4 Cystic fibrosis (CF) is the most common autosomal recessive lethal hereditary disorder in Caucasians. The majority of cystic fibrosis patients die as a result of progressive pulmonary disease. Airway inflammation, characterized by an excessive and persistent neutrophilic infiltration, is key for the pathogenesis of CF lung disease, and ultimately leads to lung destruction.Product Name: GSH (Glutathione)
Product Code: TAD 600
INN or Proposed INN: Glutathione
Other descriptive name: reduced glutathione
Mukoviszidose Institut gGmbH i. G.NULLNot RecruitingFemale: yes
Male: yes
160Germany