299. Cystic fibrosis
1,592 clinical trials,   1,539 drugs   (DrugBank: 255 drugs),   81 drug target genes,   162 drug target pathways

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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
26 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-004558-13-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;United States;France;Greece;Canada;Argentina;Poland;Germany
2EUCTR2016-004558-13-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 3United States;France;Portugal;Greece;Canada;Argentina;Poland
3EUCTR2016-004558-13-GR
(EUCTR)
07/07/202014/05/2020Treatment for bronchiectasis not due to cystic fibrosis.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;France;Canada;Greece;Argentina;Poland
4EUCTR2015-002743-33-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]
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
420Phase 3Portugal;Greece;Belgium;Spain;Australia;Israel;Germany;Netherlands;New Zealand;Italy;United Kingdom;Switzerland
5EUCTR2015-002743-33-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;Switzerland;United Kingdom;Italy;France;Belgium;Australia;Germany;Netherlands;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03460704
(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 SpANULLRecruiting18 Years90 YearsAll420Phase 3United States;Argentina;Australia;Canada;France;Germany;Greece;Israel;Italy;New Zealand;Poland;Portugal
7EUCTR2016-004558-13-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;France;Canada;Argentina;Poland
8EUCTR2015-002743-33-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: 20.1;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
420Phase 3Portugal;Greece;Spain;Israel;Switzerland;United Kingdom;Italy;France;Belgium;Australia;Germany;Netherlands;New Zealand
9NCT03093974
(ClinicalTrials.gov)
June 1, 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 SpANULLActive, not recruiting18 YearsN/AAll420Phase 3Australia;Belgium;Germany;Greece;Israel;Italy;Netherlands;New Zealand;Portugal;Spain;Switzerland;United Kingdom
10EUCTR2016-004558-13-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
264Phase 3United States;France;Canada;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2015-002743-33-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]
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;Switzerland;United Kingdom;Italy;France;Belgium;Australia;Germany;Netherlands;New Zealand
12EUCTR2015-002743-33-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
13EUCTR2015-002743-33-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
14EUCTR2016-001785-29-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
15EUCTR2015-003662-87-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2013-004987-80-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
17EUCTR2013-004295-35-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)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Austria
18NCT02288429
(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
19EUCTR2011-000192-13-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
20EUCTR2011-000192-13-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2011-000192-13-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
22EUCTR2008-005045-34-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
23EUCTR2008-005045-34-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
24EUCTR2004-003675-36-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
25EUCTR2004-003675-36-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2004-003675-36-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