299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details


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

  
22 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2013-005357-79-SE
(EUCTR)
01/06/201602/04/2016Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Turkey;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;New Zealand;Sweden
2EUCTR2013-005357-79-BG
(EUCTR)
12/02/201611/01/2016Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
3EUCTR2013-005357-79-GR
(EUCTR)
02/02/201617/12/2015Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
4EUCTR2013-005357-79-IT
(EUCTR)
18/11/201406/06/2014Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 17.0;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Sweden
5EUCTR2013-005357-79-HU
(EUCTR)
13/11/201406/06/2014Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 18.0;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
6EUCTR2013-005357-79-CZ
(EUCTR)
15/10/201404/06/2014Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 19.0;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
7EUCTR2013-005357-79-SK
(EUCTR)
11/09/201426/08/2014Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
PHARMAXIS LTDNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Sweden
8NCT02134353
(ClinicalTrials.gov)
September 201416/4/2014A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsCystic FibrosisDrug: Inhaled mannitol;Drug: Placebo Comparator: Arm B - ControlPharmaxisNULLCompleted18 Years99 YearsAll423Phase 3United States;Argentina;Australia;Belgium;Canada;Czechia;Hungary;Israel;Italy;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;France
9EUCTR2013-005357-79-BE
(EUCTR)
20/08/201401/07/2014Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 17.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
10EUCTR2012-002699-14-IT
(EUCTR)
28/05/201420/02/2014Trial of inhaled mannitol in children with cystic fibrosisA randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years Cystic fibrosis in children aged 6 to 17 years
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: Bronchitol
Product Name: Bronchitol
Product Code: N/A
INN or Proposed INN: mannitol
Other descriptive name: N/A
Pharmaxis Ltd.NULLNot RecruitingFemale: yes
Male: yes
160Argentina;Belgium;Netherlands;United Kingdom;Italy;Canada
11EUCTR2012-002699-14-NL
(EUCTR)
10/03/201402/10/2013Trial of inhaled mannitol in children with cystic fibrosisA randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years Cystic fibrosis in children aged 6 to 17 years
MedDRA version: 18.0;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: Bronchitol
Product Name: Bronchitol
Product Code: N/A
INN or Proposed INN: mannitol
Other descriptive name: N/A
Pharmaxis Ltd.NULLNot RecruitingFemale: yes
Male: yes
160Argentina;France;Canada;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
12EUCTR2012-002699-14-BE
(EUCTR)
18/06/201315/02/2013Trial of inhaled mannitol in children with cystic fibrosisA randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years Cystic fibrosis in children aged 6 to 17 years
MedDRA version: 17.1;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: Bronchitol
Product Name: Bronchitol
Product Code: N/A
INN or Proposed INN: mannitol
Other descriptive name: N/A
Pharmaxis Ltd.NULLNot RecruitingFemale: yes
Male: yes
160France;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom;Switzerland
13NCT01883531
(ClinicalTrials.gov)
June 201317/6/2013Crossover Trial Determining the Efficacy of Dry Powder Mannitol to Improve Lung Function in Subjects Aged 6-17 YearsA Randomised, Multicentre, Double-blind, Placebo-controlled, Crossover Trial Determining the Efficacy of Dry Powder Mannitol in Improving Lung Function in Subjects With Cystic Fibrosis Aged Six to Seventeen YearsCystic FibrosisDrug: Inhaled Mannitol;Drug: Inhaled PlaceboPharmaxisNULLCompleted6 Years17 YearsBoth95Phase 2United Kingdom
14EUCTR2012-002699-14-GB
(EUCTR)
28/01/201303/07/2012Trial of inhaled mannitol in children with cystic fibrosisA randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years Cystic fibrosis in children aged 6 to 17 years
MedDRA version: 14.1;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: Bronchitol
Product Name: Bronchitol
Product Code: N/A
INN or Proposed INN: mannitol
Other descriptive name: N/A
Pharmaxis Ltd.NULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Canada;Argentina;Belgium;Netherlands;Italy;United Kingdom
15EUCTR2008-002740-42-NL
(EUCTR)
10/08/200925/03/2009Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy StudyLong Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Inhaled Dry Powder Mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: MTT
INN or Proposed INN: Mannitol
Pharmaxis Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
300Germany;Netherlands;Belgium;France
16EUCTR2008-008228-34-GB
(EUCTR)
28/01/200929/07/2010Determination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in cystic fibrosis patientsDetermination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in cystic fibrosis patients Cystic Fibrosis
MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: IDPM: Inhaled Dry Powder Mannitol
Product Code: IDPM
INN or Proposed INN: MANNITOL
Pharmaxis LtdNULLNot RecruitingFemale: yes
Male: yes
18United Kingdom
17NCT00792714
(ClinicalTrials.gov)
December 200816/11/2008Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis PatientsDetermination of the Pharmacokinetics of Inhaled Mannitol After Single and Multiple Dosing in Cystic Fibrosis PatientsCystic FibrosisDrug: MannitolPharmaxisNULLCompleted6 YearsN/ABoth18Phase 1Australia;United Kingdom
18NCT00630812
(ClinicalTrials.gov)
September 200827/2/2008Long Term Administration of Inhaled Mannitol in Cystic FibrosisLong Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy StudyCystic FibrosisDrug: inhaled mannitol;Drug: Placebo comparatorPharmaxisethica Clinical Research Inc.;Europe: KasaConsult bvba, Hoegaarden, Belgium;Argentina: Resolution Latin America; Buenos Aires, ArgentinaCompleted6 YearsN/AAll318Phase 3United States;Argentina;Belgium;Canada;France;Germany;Netherlands
19NCT00117208
(ClinicalTrials.gov)
November 200530/6/2005Comparison of Inhaled Mannitol and rhDNase in Children With Cystic FibrosisA Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic FibrosisCystic FibrosisDrug: mannitol;Drug: mannitol + pulmozyme;Drug: Dornase alphaPharmaxisNULLCompleted8 Years18 YearsBoth20Phase 2United Kingdom
20EUCTR2004-001888-21-GB
(EUCTR)
03/12/200422/02/2005A cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic FibrosisA cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic Fibrosis Cystic fibrosis (CF)Product Name: DP Mannitol
INN or Proposed INN: Mannitol
Trade Name: Pulmozyme (dornase alfa)
Product Name: Pulmozyme (dornase alfa)
INN or Proposed INN: Dornase alfa
Other descriptive name: rhDNAse
Pharmaxis LtdNULLNot Recruiting Female: yes
Male: yes
42 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
21NCT00455130
(ClinicalTrials.gov)
March 20042/4/2007A Phase 2 Study to Determine the Safety and Efficacy of Inhaled Dry Powder Mannitol in Cystic FibrosisCystic FibrosisDrug: Inhaled mannitolPharmaxisNULLCompleted8 YearsN/ABothPhase 2Australia;New Zealand
22EUCTR2012-002699-14-FR
(EUCTR)
20/09/2012Trial of inhaled mannitol in children with cystic fibrosisA randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years Cystic fibrosis in children aged 6 to 17 years
MedDRA version: 15.0;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: Bronchitol
Product Name: Bronchitol
Product Code: N/A
INN or Proposed INN: mannitol
Other descriptive name: N/A
Pharmaxis Ltd.NULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Canada;Argentina;Belgium;Spain;Austria;Netherlands;Germany;Italy;United Kingdom