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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2010-019802-17-IE (EUCTR) | 15/12/2010 | 09/09/2010 | Tiotropium-bromide in 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: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 440 | Hungary;Portugal;Germany;Switzerland;France;Ireland;Italy;Austria;South Africa;Australia;Israel;United Kingdom;Slovakia;Russian Federation;Czech Republic;Canada;Belgium;Spain;United States;Poland | |||
| 2 | EUCTR2010-019802-17-ES (EUCTR) | 29/11/2010 | 22/09/2010 | Ensayo 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.A | NULL | Not Recruiting | Female: yes Male: yes | 360 | Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Ireland;Spain;Italy;Austria | ||||
| 3 | EUCTR2010-019802-17-DE (EUCTR) | 25/11/2010 | 04/08/2010 | Clinical 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. KG | NULL | Not Recruiting | Female: yes Male: yes | 372 | Portugal;United States;Slovakia;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;South Africa;Germany | |||
| 4 | EUCTR2010-019802-17-BE (EUCTR) | 23/11/2010 | 11/08/2010 | Tiotropium-bromide in cystic fibrosic | 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: 14.0;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.V | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Portugal;United States;Slovakia;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;South Africa;Germany | ||
| 5 | EUCTR2010-019802-17-GB (EUCTR) | 22/10/2010 | 10/08/2010 | Tiotropium-bromide in 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: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 471 | Hungary;Portugal;Germany;Switzerland;France;Ireland;Italy;Austria;South Africa;Australia;Israel;Slovakia;Russian Federation;United Kingdom;Czech Republic;Canada;Belgium;Spain;United States;Poland | |||
| 6 | EUCTR2010-019802-17-AT (EUCTR) | 20/10/2010 | 09/09/2010 | 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: 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 | ,NULL | Not Recruiting | Female: yes Male: yes | Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria | |||||
| 7 | EUCTR2010-019802-17-CZ (EUCTR) | 01/10/2010 | 16/08/2010 | Tiotropium-bromide in cystic fibrosic | 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: 14.0;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 Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 360 | Portugal;United States;Slovakia;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;South Africa;Germany | |||
| 8 | EUCTR2010-019802-17-HU (EUCTR) | 30/09/2010 | 23/07/2010 | 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 | 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 KG | NULL | Not Recruiting | Female: yes Male: yes | 360 | Portugal;Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria | ||||
| 9 | EUCTR2010-019802-17-FR (EUCTR) | 14/09/2010 | 23/07/2010 | 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. | 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 | 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 | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Ireland;Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 10 | EUCTR2010-019802-17-SK (EUCTR) | 13/09/2010 | 03/08/2010 | 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. | 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 | 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 | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | France;Portugal;Czech Republic;Hungary;Slovakia;Spain;Belgium;Ireland;Austria;Germany;Italy;United Kingdom | ||
| 11 | EUCTR2010-019802-17-PT (EUCTR) | 13/09/2010 | 07/07/2010 | 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 | 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 France | NULL | Not Recruiting | Female: yes Male: yes | 360 | Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria | ||||
| 12 | NCT01179347 (ClinicalTrials.gov) | September 2010 | 10/8/2010 | Tiotropium Bromide in Cystic Fibrosis | 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. | Cystic Fibrosis | Drug: tiotropium Respimat® inhaler;Drug: Placebo Respimat® inhaler | Boehringer Ingelheim | NULL | Completed | N/A | N/A | All | 464 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Ireland;Israel;Italy;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Switzerland;United Kingdom |
| 13 | EUCTR2010-019802-17-IT (EUCTR) | 27/07/2010 | 20/08/2010 | A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 micrograms administered once daily via the Respimat device in patients with cystic fibrosis. - ND | Patients with cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762 | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation INN or Proposed INN: Tiotropium bromide | BOEHRINGER ING. | NULL | Not Recruiting | Female: yes Male: yes | 440 | Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria | ||||
| 14 | EUCTR2008-001156-43-IT (EUCTR) | 27/07/2009 | 28/07/2009 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Portugal;France;Belgium;Netherlands;Germany;United Kingdom;Italy | |||
| 15 | EUCTR2008-001156-43-PT (EUCTR) | 23/06/2009 | 05/05/2009 | 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. | 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. | NULL | Not Recruiting | Female: yes Male: yes | 596 | Portugal;United Kingdom;Germany;Netherlands;Belgium;France;Italy | |||
| 16 | EUCTR2008-001156-43-NL (EUCTR) | 15/01/2009 | 15/09/2008 | 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. - Tiotropium in CF | 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. - 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 bv | NULL | Not Recruiting | Female: yes Male: yes | 596 | Portugal;United Kingdom;Germany;Netherlands;Belgium;France;Italy | |||
| 17 | EUCTR2008-001156-43-DE (EUCTR) | 15/10/2008 | 18/07/2008 | 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. | 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.KG | NULL | Not Recruiting | Female: yes Male: yes | 596 | Portugal;France;Belgium;Netherlands;Germany;Italy;United Kingdom | |||
| 18 | EUCTR2008-001156-43-FR (EUCTR) | 19/09/2008 | 13/06/2008 | 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. | 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 France | NULL | Not Recruiting | Female: yes Male: yes | 596 | Phase 2 | Portugal;France;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 19 | EUCTR2008-001156-43-GB (EUCTR) | 11/09/2008 | 14/10/2008 | 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. | 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 596 | Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Italy | |||
| 20 | NCT00737100 (ClinicalTrials.gov) | September 2008 | 15/8/2008 | Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in 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 mcg and 5 mcg) Administered Once Daily Via the Respimat Device for 12 Weeks in Patients With Cystic Fibrosis. | Cystic Fibrosis | Drug: Placebo Respimat;Drug: Tiotropium bromide 5 mcg;Drug: tiotropium bromide-low dose-2.5mcg | Boehringer Ingelheim | NULL | Completed | N/A | N/A | All | 510 | Phase 2 | United States;Australia;Belgium;France;Germany;Italy;Netherlands;New Zealand;Portugal;Russian Federation;United Kingdom |
| 21 | EUCTR2008-001156-43-BE (EUCTR) | 22/07/2008 | 16/06/2008 | 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. | 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.V | NULL | Not Recruiting | Female: yes Male: yes | 596 | Portugal;United Kingdom;Germany;Netherlands;Belgium;France;Italy | |||
| 22 | NCT02172534 (ClinicalTrials.gov) | September 2006 | 20/6/2014 | Safety, Tolerability and Pharmacokinetics of Tiotropium in Cystic Fibrosis Patients | A Randomized, Double-blind Within Dose, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single and Multiple Doses (28-day Dosing) of Tiotropium Bromide Administered Once Daily Via the Respimat® Device in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Tiotropium bromide low;Drug: Tiotropium bromide medium;Drug: Tiotropium bromide high;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | N/A | N/A | Both | 113 | Phase 1 | NULL |