Tiotropium Respimat ( DrugBank: Tiotropium )


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20

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
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2010-019802-17-IE
(EUCTR)
15/12/201009/09/2010Tiotropium-bromide in cystic fibrosisA randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. - Cystic Fibrosis
MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
440Hungary;Portugal;Germany;Switzerland;France;Ireland;Italy;Austria;South Africa;Australia;Israel;United Kingdom;Slovakia;Russian Federation;Czech Republic;Canada;Belgium;Spain;United States;Poland
2EUCTR2010-019802-17-ES
(EUCTR)
29/11/201022/09/2010Ensayo clínico aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para confirmar eficacia y seguridad del tratamiento durante 12 semanas con tiotropio 5mcg una vez al día inhalado via Respimat® en pacientes con fibrosis quística.A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 mcg administered once daily via the Respimat® device in patients with cystic fibrosis. - Fibrosis QuísticaCystic Fibrosis Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer Ingelheim España, S.ANULLNot RecruitingFemale: yes
Male: yes
360Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Ireland;Spain;Italy;Austria
3EUCTR2010-019802-17-DE
(EUCTR)
25/11/201004/08/2010Clinical trial to confirm the efficacy and safety of tiotropium 5 microgram administered via Respimat device, in patients with cystic fibrosis.A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. Cystic Fibrosis
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: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
INN or Proposed INN: Tiotropium Bromide (monohydrate)
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
372Portugal;United States;Slovakia;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;South Africa;Germany
4EUCTR2010-019802-17-BE
(EUCTR)
23/11/201011/08/2010Tiotropium-bromide in cystic fibrosicA randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. Cystic Fibrosis
MedDRA version: 14.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Portugal;United States;Slovakia;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;South Africa;Germany
5EUCTR2010-019802-17-GB
(EUCTR)
22/10/201010/08/2010Tiotropium-bromide in cystic fibrosisA randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. - Cystic Fibrosis
MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
471Hungary;Portugal;Germany;Switzerland;France;Ireland;Italy;Austria;South Africa;Australia;Israel;Slovakia;Russian Federation;United Kingdom;Czech Republic;Canada;Belgium;Spain;United States;Poland
6EUCTR2010-019802-17-AT
(EUCTR)
20/10/201009/09/2010A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. - Cystic Fibrosis
MedDRA version: 12.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
MedDRA version: 12.1;Level: PT;Term: Cystic fibrosis
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer Ingelheim RCV GmbH & Co KG,NULLNot RecruitingFemale: yes
Male: yes
Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria
7EUCTR2010-019802-17-CZ
(EUCTR)
01/10/201016/08/2010Tiotropium-bromide in cystic fibrosicA randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. Cystic Fibrosis
MedDRA version: 14.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
360Portugal;United States;Slovakia;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;South Africa;Germany
8EUCTR2010-019802-17-HU
(EUCTR)
30/09/201023/07/2010A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. - Cystic fibrosis Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 microgram
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
360Portugal;Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria
9EUCTR2010-019802-17-FR
(EUCTR)
14/09/201023/07/2010A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis.A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. Cystic FibrosisTrade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Ireland;Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Germany;Italy;United Kingdom
10EUCTR2010-019802-17-PT
(EUCTR)
13/09/201007/07/2010A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. - Cystic Fibrosis Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
360Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria
11EUCTR2010-019802-17-SK
(EUCTR)
13/09/201003/08/2010A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis.A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. Cystic fibrosisTrade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer Ingelheim RCV GmbH&Co KGNULLNot RecruitingFemale: yes
Male: yes
360Phase 3France;Portugal;Czech Republic;Hungary;Slovakia;Spain;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
12NCT01179347
(ClinicalTrials.gov)
September 201010/8/2010Tiotropium Bromide in Cystic FibrosisA Randomised, Double-blind, Placebo-controlled Parallel-group Trial to Confirm the Efficacy After 12 Weeks and the Safety of Tiotropium 5 Mcg Administered Once Daily Via the Respimat® Device in Patients With Cystic Fibrosis.Cystic FibrosisDrug: tiotropium Respimat® inhaler;Drug: Placebo Respimat® inhalerBoehringer IngelheimNULLCompletedN/AN/AAll464Phase 3United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Ireland;Israel;Italy;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Switzerland;United Kingdom
13EUCTR2008-001156-43-IT
(EUCTR)
27/07/200928/07/2009A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 micrograms and 5 micrograms) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosisA randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 micrograms and 5 micrograms) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis cystic fibrosis
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: Spiriva Respimat 2.5 microgram, solution for inhalation
INN or Proposed INN: Tiotropium bromide
Product Name: Tiotropium Respimat 1.25 micrograms solution for inhalation
Product Code: NA
INN or Proposed INN: Tiotropium bromide
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
600Portugal;France;Belgium;Netherlands;Germany;United Kingdom;Italy
14EUCTR2008-001156-43-PT
(EUCTR)
23/06/200905/05/2009A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. Cystic fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
INN or Proposed INN: Tiotropium
Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation
INN or Proposed INN: Tiotropium
Boehringer Ingelheim Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
596Portugal;United Kingdom;Germany;Netherlands;Belgium;France;Italy
15EUCTR2008-001156-43-NL
(EUCTR)
15/01/200915/09/2008A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. - Tiotropium in CFA randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. - Tiotropium in CF Cystic fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Other descriptive name: TIOTROPIUM
Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation
Other descriptive name: TIOTROPIUM
Boehringer Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
596Portugal;United Kingdom;Germany;Netherlands;Belgium;France;Italy
16EUCTR2008-001156-43-DE
(EUCTR)
15/10/200818/07/2008A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. Cystic fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
INN or Proposed INN: tiotropium bromide monohydrate
Product Name: Tiotropium Respimat 1.25 microgram, solution for inhalation
Product Code: N/A
INN or Proposed INN: tiotropium bromide monohydrate
Boehringer Ingelheim Pharma GmbH & Co.KGNULLNot RecruitingFemale: yes
Male: yes
596Portugal;France;Belgium;Netherlands;Germany;Italy;United Kingdom
17EUCTR2008-001156-43-FR
(EUCTR)
19/09/200813/06/2008A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. Cystic fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Other descriptive name: TIOTROPIUM
Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation
Other descriptive name: TIOTROPIUM
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
596Phase 2Portugal;France;Belgium;Netherlands;Germany;Italy;United Kingdom
18EUCTR2008-001156-43-GB
(EUCTR)
11/09/200814/10/2008A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. Cystic fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Other descriptive name: TIOTROPIUM
Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation
Other descriptive name: TIOTROPIUM
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
596Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Italy
19NCT00737100
(ClinicalTrials.gov)
September 200815/8/2008Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic FibrosisA Randomized, Double-blind, Placebo-controlled Parallel Group Study to Investigate the Safety and Efficacy of Two Doses of Tiotropium Bromide (2.5 mcg and 5 mcg) Administered Once Daily Via the Respimat Device for 12 Weeks in Patients With Cystic Fibrosis.Cystic FibrosisDrug: Placebo Respimat;Drug: Tiotropium bromide 5 mcg;Drug: tiotropium bromide-low dose-2.5mcgBoehringer IngelheimNULLCompletedN/AN/AAll510Phase 2United States;Australia;Belgium;France;Germany;Italy;Netherlands;New Zealand;Portugal;Russian Federation;United Kingdom
20EUCTR2008-001156-43-BE
(EUCTR)
22/07/200816/06/2008A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. Cystic fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Other descriptive name: TIOTROPIUM
Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation
Other descriptive name: TIOTROPIUM
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
596Portugal;United Kingdom;Germany;Netherlands;Belgium;France;Italy