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


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

  
14 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT05740618
(ClinicalTrials.gov)
March 1, 20233/2/2023Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic FibrosisEffect of Bronchitol on Mucociliary Clearance in Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)-Modulator Treated Patients With Cystic Fibrosis With Moderate to Severe Lung DiseaseCystic FibrosisDrug: Mannitol Inhalant ProductUniversity of North Carolina, Chapel HillChiesi USA, Inc.Not yet recruiting18 YearsN/AAll25Phase 4United States
2EUCTR2013-005357-79-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
3EUCTR2013-005357-79-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
4EUCTR2013-005357-79-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
5EUCTR2013-005357-79-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
6EUCTR2013-005357-79-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
7EUCTR2013-005357-79-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
8EUCTR2013-005357-79-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
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
160Canada;Argentina;Belgium;Netherlands;United Kingdom;Italy
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
13EUCTR2012-002699-14-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
14EUCTR2012-002699-14-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