COLISTIMETHATE ( DrugBank: Colistimethate )


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35

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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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
Inclusion_
gender
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PhaseCountries
1EUCTR2022-000476-18-HU
(EUCTR)
24/05/202231/03/2022A study to test how well inhalation of Colistimethate Sodium once a day is tolerated and how safe it is compared with inhalation of Colistimethate Sodium two times a day in adult and children with Cystic Fibrosis and lung infection (COPILOT)Tolerability and Safety of Inhaled Colistimethate Sodium Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection (COPILOT) - COPILOT Chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Colfinair 2 MIU Powder for Nebuliser Solution
Product Name: Colistimethate sodium (CMS)
INN or Proposed INN: COLISTIMETHATE SODIUM
EnBiotix, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
38Phase 3Hungary;Slovakia;Greece;Poland;Australia;Bulgaria;United Kingdom
2EUCTR2016-004558-13-DE
(EUCTR)
01/12/202009/04/2020A 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, 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) - PROMIS II 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, 1 million International Units (IU) Powder for Nebuliser Solution
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;France;United States;Greece;Canada;Argentina;Poland;Germany;Italy
3EUCTR2016-004558-13-IT
(EUCTR)
19/10/202021/10/2020A 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 bronchiectasischronically 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 colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasischronically infected with Pseudomonas aeruginosa (P. aeruginosa) - Promis II 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
Product Name: Colistimethate sodium
Product Code: [NA]
Other descriptive name: Colistimethate Sodium
Trade Name: Salbutamol-ratiopharm® N metered-dose aerosol inhaler
Product Name: Salbutamol-ratiopharm® N metereddose aerosol inhaler
Product Code: [Salbutamol]
INN or Proposed INN: SALBUTAMOL
Other descriptive name: Salbutamol
ZAMBON SPANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;United States;France;Greece;Canada;Argentina;Poland;Germany;Italy
4EUCTR2016-004558-13-PT
(EUCTR)
27/07/202020/04/2020A 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, 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) - PROMIS II 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, 1 million International Units (IU) Powder for Nebuliser Solution
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 3France;United States;Portugal;Greece;Canada;Argentina;Poland;Germany;Italy
5EUCTR2016-004558-13-GR
(EUCTR)
07/07/202014/05/2020A 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, 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) - PROMIS II 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, 1 million International Units (IU) Powder for Nebuliser Solution
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;France;United States;Canada;Greece;Argentina;Poland;Australia;Israel;Germany;Italy;New Zealand
6EUCTR2015-002743-33-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
7EUCTR2015-002743-33-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
8NCT03460704
(ClinicalTrials.gov)
January 29, 201814/2/2018Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium (PROMIS II)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)Non Cystic Fibrosis BronchiectasisDrug: Colistimethate sodium;Drug: Saline SolutionZambon SpANULLCompleted18 Years90 YearsAll287Phase 3United States;Argentina;Australia;Canada;France;Germany;Greece;Israel;Italy;New Zealand;Poland;Portugal
9EUCTR2016-004558-13-PL
(EUCTR)
14/08/201730/06/2017A 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, 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) - PROMIS II 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, 1 million International Units (IU) Powder for Nebuliser Solution
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 3United States;Portugal;France;Canada;Greece;Argentina;Poland;Australia;Israel;Germany;New Zealand;Italy
10EUCTR2015-002743-33-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
11NCT03093974
(ClinicalTrials.gov)
June 6, 20179/3/2017Long Term Efficacy and Safety of Inhaled Colistimethate Sodium in Bronchiectasis Subjects With Chronic Pseudomonas Aeruginosa Infection.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)Non Cystic Fibrosis BronchiectasisDrug: Colistimethate Sodium;Drug: Saline SolutionZambon SpANULLCompleted18 YearsN/AAll377Phase 3Australia;Belgium;Germany;Greece;Israel;Italy;Netherlands;New Zealand;Portugal;Spain;Switzerland;United Kingdom
12EUCTR2016-004558-13-FR
(EUCTR)
30/05/201720/03/2017A 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 II 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, 1 million International Units (IU) Powder for Nebuliser Solution
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLNot RecruitingFemale: yes
Male: yes
264Phase 3Portugal;United States;France;Greece;Canada;Poland;Germany;Italy
13EUCTR2015-002743-33-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
14EUCTR2015-002743-33-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
15EUCTR2015-002743-33-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
16EUCTR2015-002743-33-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
17EUCTR2016-001785-29-IE
(EUCTR)
15/08/201610/05/2016Study of the effects of combined treatment with the CFTR corrector ivacaftor and IV antibiotics on infection in CF.Combined Effect of CFTR Modifiers and Intensive Antibiotic Treatment Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Kalydeco
INN or Proposed INN: IVACAFTOR
Trade Name: Ciprofloxacin
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE
Product Name: Flucloxicillin
INN or Proposed INN: FLUCLOXACILLIN SODIUM
Trade Name: Fortum
INN or Proposed INN: CEFTAZIDIME
Product Name: Tobramycin
INN or Proposed INN: TOBRAMYCIN SULFATE
Trade Name: Meropenem
INN or Proposed INN: Meropenem
Other descriptive name: MEROPENEM
Trade Name: Colistin
INN or Proposed INN: COLISTIMETHATE SODIUM
St. Vincent's University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Ireland
18EUCTR2015-003662-87-DK
(EUCTR)
13/11/201522/09/2015Pseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of lifePseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of life - Pseudomonas, Tazocin or Colistin Chronic pulmonary disease patients, except cystic fibrosis patients, with confirmed pulmonary infection by sputum sample positive for Pseudomonas Aeruginosa.
MedDRA version: 18.1;Level: LLT;Classification code 10051190;Term: Pneumonia Pseudomonas aeruginosa;System Organ Class: 100000004862
MedDRA version: 18.1;Classification code 10050700;Term: Chronic respiratory disease NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: colistimethate sodium (promixin)
INN or Proposed INN: COLISTIMETHATE SODIUM
Trade Name: Piperacillin with Tazobactam (tazocin)
INN or Proposed INN: PIPERACILLIN
Other descriptive name: PIPERACILLIN
INN or Proposed INN: TAZOBACTAM
Other descriptive name: TAZOBACTAM
Aarhus University Hospital, Department of Respiratory MedicineNULLNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
19EUCTR2012-001565-33-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
20EUCTR2013-004987-80-BE
(EUCTR)
28/08/201418/02/2014Colistin dosage through blood samples and sputum in Cystic Fibrosis (CF) populationColistin use in Cystic Fibrosis patients: pharmacokinetic studies (intravenous administration) in relation with pharmacodynamics, tolerance profile and risk of selection of resistance. Colistin use in Cystic Fibrosis patients
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: COLISTINEB 2MUI
INN or Proposed INN: Colistineb
Other descriptive name: COLISTIMETHATE SODIUM (A COMPONENT)
CUB - Hôpital ErasmeNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Belgium
21EUCTR2013-004295-35-AT
(EUCTR)
30/04/201402/04/2014Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept studyLung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study - LCI-OUT Chronic lung P. Aeruginosa Infection
MedDRA version: 16.1;Level: PT;Classification code 10061229;Term: Lung infection;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler
Product Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler
INN or Proposed INN: aztreonam
Other descriptive name: AZTREONAM LYSINE
Trade Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel
Product Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel
INN or Proposed INN: COLISTIMETHATE SODIUM
Trade Name: TOBI
Product Name: Tobi
INN or Proposed INN: TOBRAMYCIN SULFATE
Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III)NULLNot RecruitingFemale: yes
Male: yes
15Phase 4Austria
22NCT02113397
(ClinicalTrials.gov)
April 20149/4/2014Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis LungComparative Evaluation of Bacterial Diversity and Richness in CF Lung in Patients Who Use Cycled Every Other Month Tobramycin Inhalation Powder (TOBI™ Podhaler™) Or Continuous Alternating Therapy With Tobramycin Inhalation Powder (TOBI™ Podhaler™) and Inhaled ColistimethateCystic FibrosisDrug: TOBI™ Podhaler™ 112 mg inhaled twice daily;Drug: Colistimethate 75 mg inhaled two times dailyDartmouth-Hitchcock Medical CenterNovartis PharmaceuticalsTerminated12 Years75 YearsAll1United States
23NCT02288429
(ClinicalTrials.gov)
September 201315/9/2014Evaluation of Pharmacokinetic and Pharmacodynamic Properties of Intravenous Colistimethate SodiumEvaluation of Steady-state Pharmacokinetic and Pharmacodynamic Properties of Intravenous Colistimethate Sodium in Cystic Fibrosis and Critically Ill PatientsColistinDrug: colistimethate sodiumUniversity of Colorado, DenverNULLCompleted18 Years89 YearsAll16United States
24NCT01844778
(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
25EUCTR2012-001565-33-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
26EUCTR2012-001565-33-GB
(EUCTR)
21/06/201316/04/2013An 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: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 17.1;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 Recruiting Female: yes
Male: yes
67 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSpain;Ireland;Germany;Switzerland;United Kingdom
27EUCTR2012-001565-33-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
28EUCTR2011-000192-13-PL
(EUCTR)
08/07/201131/05/2011A study to investigate the drug levels of colistimethate sodium after inhalation of Colobreathe® in subjects with cystic fibrosisA 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study systemic exposure of colobreathe in cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa
MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 13.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Colobreathe
Product Code: N/A
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate
Forest Laboratories UK Ltd.NULLNot RecruitingFemale: yes
Male: yes
28Poland;Ukraine;Germany;United Kingdom
29EUCTR2011-000192-13-DE
(EUCTR)
05/05/201105/04/2011A study to investigate the drug levels of colistimethate sodium after inhalation of Colobreathe® in subjects with cystic fibrosisA 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study systemic exposure of colobreathe in cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa
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;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Colobreathe
Product Code: N/A
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate
Forest Laboratories UK Ltd.NULLNot RecruitingFemale: yes
Male: yes
40Poland;Ukraine;Germany;United Kingdom
30EUCTR2011-000192-13-GB
(EUCTR)
28/04/201117/03/2011A 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) studyA 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa
MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 13.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Name: Colobreathe
Product Code: N/A
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate
Forest Laboratories UK Ltd.NULLNot RecruitingFemale: yes
Male: yes
28Germany;United Kingdom;Poland
31EUCTR2008-005045-34-IE
(EUCTR)
09/07/201018/05/2010A double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasisA double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasis non-CF bronchiectasis (CF = cystic fibrosis)
MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis
Trade Name: Promixin 1 million International Units (IU) Powder for Nebuliser Solution
Other descriptive name: colistimethate sodium
Profile Pharma LtdNULLNot RecruitingFemale: yes
Male: yes
260United Kingdom;Ireland
32EUCTR2008-005045-34-GB
(EUCTR)
15/12/200817/10/2008A clinical study to investigate the effect and safety of up to 6 months of treatment with inhaled Promixin in the treatment of chest infections causeed by Pseudomonas in people with a lung disease called bronchiectasisA double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasis non-CF bronchiectasis (CF = cystic fibrosis)
MedDRA version: 14.0;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 1 million International Units (IU) Powder for Nebuliser Solution
Other descriptive name: colistimethate sodium
Profile Pharma LtdNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Ukraine;Ireland;Russian Federation;United Kingdom
33EUCTR2004-003675-36-BE
(EUCTR)
27/10/200513/10/2005A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infectionA randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis.Product Name: Colobreathe
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colomycin
Trade Name: TOBI 300 mg/5 ml Nebuliser Solution
Product Name: TOBI®
INN or Proposed INN: Tobramycin
Other descriptive name: TOBI®
Forest Laboratories UK LtdNULLNot RecruitingFemale: yes
Male: yes
360Denmark;Belgium
34EUCTR2004-003675-36-DK
(EUCTR)
28/04/200506/12/2004A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infectionA randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis.Product Name: Colobreathe
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colomycin
Product Name: TOBI®
INN or Proposed INN: Tobramycin
Other descriptive name: TOBI®
Forest Laboratories UK LtdNULLNot RecruitingFemale: yes
Male: yes
360Belgium;Denmark
35EUCTR2004-003675-36-AT
(EUCTR)
19/04/200515/03/2005A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infectionA randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis.Product Name: Colobreathe
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colomycin
Trade Name: TOBI 300 mg/5 ml Nebuliser Solution
Product Name: TOBI®
INN or Proposed INN: Tobramycin
Other descriptive name: TOBI®
Forest Laboratories UK LtdNULLNot RecruitingFemale: yes
Male: yes
360Belgium;Denmark;Austria