Bi 1265162 25 µg    (DrugBank: -)

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6

299. 嚢胞性線維症 [臨床試験数:1,592,薬物数:1,539(DrugBank:255),標的遺伝子数:81,標的パスウェイ数:162
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.
6 / 1,592 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-000261-21-GB
(EUCTR)
05/11/201905/06/2019A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler - BALANCE - CF(TM) 1A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis - BALANCE - CF(TM) 1 Cystic Fibrosis
MedDRA version: 20.0;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]
Product Name: BI 1265162 10 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 25 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 50 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 100 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden
2EUCTR2019-000261-21-ES
(EUCTR)
10/10/201905/07/2019A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhalerA randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis Cystic Fibrosis
MedDRA version: 20.0;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]
Product Name: BI 1265162 10 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 25 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 50 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 100 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Boehringer Ingelheim, S.A.NULLNot RecruitingFemale: yes
Male: yes
98Phase 2Spain;United States;France;Canada;Belgium;Ireland;Germany;United Kingdom;Sweden
3EUCTR2019-000261-21-SE
(EUCTR)
08/10/201929/04/2019A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhalerA randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis Cystic Fibrosis
MedDRA version: 20.0;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]
Product Name: BI 1265162 10 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 25 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 50 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 100 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden
4EUCTR2019-000261-21-BE
(EUCTR)
07/10/201929/05/2019A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler – BALANCE – CF(TM)1A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis – BALANCE – CF(TM)1 Cystic Fibrosis
MedDRA version: 20.0;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]
Product Name: BI 1265162 10 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 25 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 50 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 100 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden
5EUCTR2019-000261-21-FR
(EUCTR)
19/07/201921/05/2019A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhalerA randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis Cystic Fibrosis
MedDRA version: 20.0;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]
Product Name: BI 1265162 10 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 25 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 50 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 100 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-000261-21-DE
(EUCTR)
16/05/2019A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhalerA randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis Cystic Fibrosis
MedDRA version: 20.0;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]
Product Name: BI 1265162 10 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 25 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 50 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 100 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
98Phase 2France;United States;Canada;Belgium;Spain;Ireland;Germany;United Kingdom;Sweden