Fluticasone propionate ( DrugBank: Fluticasone propionate, Fluticasone )


2 diseases
IDDisease name (Link within this page)Number of trials
98Eosinophilic gastrointestinal disease11
228Bronchiolitis obliterans2

98. Eosinophilic gastrointestinal disease


Clinical trials : 171 Drugs : 184 - (DrugBank : 47) / Drug target genes : 42 - Drug target pathways : 141
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05083312
(ClinicalTrials.gov)
September 30, 20216/10/2021Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 TrialAn Adolescent Sub-study Within FLUTE-2: A Randomized, Double-blind, Placebo-Controlled Study of APT-1011 (Fluticasone Propionate Oral Dispersible Tablet Formulation), With an Open-label Extension, in Adolescent Subjects With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: APT-1011;Drug: Placebo oral tabletEllodi Pharmaceuticals, LPNULLRecruiting12 Years17 YearsAll30Phase 3United States;Australia
2EUCTR2019-001521-27-DE
(EUCTR)
03/08/202010/02/2020Study with Eosinophilic Esophagitis subjectsFluticasone propionate Oral Dispersible Tablet Formulation in Eosinophilic Esophagitis: A Two-Part, Randomized, Double-blind, Placebo-Controlled Study of APT-1011 in Adult and Adolescent Subjects with Eosinophilic Esophagitis - FLUTE-2 Eosinophilic Esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: APT-1011
Product Code: APT-1011 - 3 mg
INN or Proposed INN: Fluticasone Propionate, USP
Other descriptive name: FLUTICASONE PROPIONATE
Adare Pharmaceuticals US, LPNULLNot RecruitingFemale: yes
Male: yes
120Phase 3United States;Spain;Australia;Germany
3EUCTR2019-001521-27-ES
(EUCTR)
04/04/202028/02/2020Study with Eosinophilic Esophagitis subjectsFluticasone propionate Oral Dispersible Tablet Formulation in Eosinophilic Esophagitis: A Two-Part, Randomized, Double-blind, Placebo-Controlled Study of APT-1011 in Adult and Adolescent Subjects with Eosinophilic Esophagitis - FLUTE-2 Eosinophilic Esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: APT-1011
Product Code: APT-1011 - 3 mg
INN or Proposed INN: Fluticasone Propionate, USP
Other descriptive name: FLUTICASONE PROPIONATE
Adare Pharmaceuticals US, LPNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Spain;Australia;Germany;Switzerland
4NCT04281108
(ClinicalTrials.gov)
January 30, 202020/2/2020Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)Fluticasone Propionate Oral Dispersible Tablet Formulation in Eosinophilic Esophagitis: A Two-Part, Randomized, Double-blind, Placebo-Controlled Study of APT-1011 With an Open-label Extension, in Adult Subjects With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: APT-1011;Drug: Placebo oral tabletEllodi Pharmaceuticals, LPNULLActive, not recruiting18 YearsN/AAll143Phase 3Germany;United States;Spain;Australia
5EUCTR2016-004749-10-DE
(EUCTR)
15/11/201726/07/2017study in subjects with Eosinophilic EsophagitisFLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis. Eosinophilic Esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: APT-1011
INN or Proposed INN: FLUTICASONE PROPIONATE
Other descriptive name: FLUTICASONE PROPIONATE
Product Name: APT-1011
Other descriptive name: FLUTICASONE PROPIONATE
Product Name: APT-1011
Other descriptive name: FLUTICASONE PROPIONATE
Adare PharmaceuticalNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Canada;Spain;Belgium;Germany;Switzerland
6EUCTR2016-004749-10-BE
(EUCTR)
06/10/201707/07/2017study in subjects with Eosinophilic EsophagitisFLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis. Eosinophilic Esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: APT-1011
INN or Proposed INN: FLUTICASONE PROPIONATE
Other descriptive name: FLUTICASONE PROPIONATE
Product Name: APT-1011
Other descriptive name: FLUTICASONE PROPIONATE
Product Name: APT-1011
Other descriptive name: FLUTICASONE PROPIONATE
Adare PharmaceuticalNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Spain;Belgium;Germany;Switzerland
7EUCTR2016-004749-10-ES
(EUCTR)
20/09/201720/09/2017study in subjects with Eosinophilic EsophagitisFLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis. Eosinophilic Esophagitis
MedDRA version: 20.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000013492;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: APT-1011
INN or Proposed INN: Fluticasone Propionate
Other descriptive name: FLUTICASONE PROPIONATE
Product Name: APT-1011
INN or Proposed INN: Fluticasone Propionate
Other descriptive name: FLUTICASONE PROPIONATE
Product Name: APT-1011
INN or Proposed INN: Fluticasone Propionate
Other descriptive name: FLUTICASONE PROPIONATE
Adare PharmaceuticalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;Canada;Belgium;Spain;Germany
8NCT02778867
(ClinicalTrials.gov)
May 20, 201612/10/2015SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet StudySix Food vs One Food Eosinophilic Esophagitis Elimination Diet (SOFEED) Followed by Swallowed Glucocorticoid TrialEosinophilic Gastrointestinal Disorders (EGIDs);Eosinophilic Esophagitis (EoE)Other: 1 Food Elimination Diet Therapy;Other: 6 Food Elimination Diet Therapy;Other: 6 Food Elimination Diet (after 1FED failure);Drug: Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)Children's Hospital Medical Center, CincinnatiNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);National Institute of Allergy and Infectious Diseases (NIAID);Office of Rare Diseases (ORD);National Center for Advancing Translational Science (NCATS)Completed18 Years60 YearsAll129Phase 2/Phase 3United States
9NCT02610816
(ClinicalTrials.gov)
March 21, 201612/10/2015Eosinophilic Esophagitis Intervention Trial-1 Food vs. 4 Food Elimination Diet Followed by Swallowed GlucocorticoidsEosinophilic Esophagitis (EoE) Intervention Trial-Randomized 1 Food Elimination vs. 4 Food Elimination Diet Followed by Swallowed GlucocorticoidsEosinophilic Esophagitis;Eosinophilic Gastrointestinal Disorders (EGIDs)Other: 1 Food Elimination Diet;Other: 4 Food Elimination Diet;Other: 4 Food Elimination Diet (post 1FED failure);Drug: Fluticasone Propionate, 800 mcg twice daily (post 4FED failure)Children's Hospital Medical Center, CincinnatiPatient-Centered Outcomes Research InstituteCompleted6 Years17 YearsAll67Phase 2/Phase 3United States
10NCT00426283
(ClinicalTrials.gov)
January 200722/1/2007A Study of Flovent in Patients With Eosinophilic EsophagitisA Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Flovent;Other: PlaceboMarc Rothenberg, MDNULLCompleted3 Years30 YearsAll42Phase 2United States
11NCT00266578
(ClinicalTrials.gov)
October 200215/12/2005A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic DisordersEffect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis; A Prospective, Randomized, Placebo-Controlled TrialEosinophilic EsophagitisDrug: Fluticasone PropionateMarc RothenbergNULLCompleted3 Years30 YearsBoth30Phase 3United States

228. Bronchiolitis obliterans


Clinical trials : 96 Drugs : 125 - (DrugBank : 34) / Drug target genes : 33 - Drug target pathways : 155
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04655508
(ClinicalTrials.gov)
May 21, 202110/11/2020Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 =10% From Pre TransplantationEfficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 =10% From Pre TransplantationStem Cell Transplant Complications;Respiratory Disease;Bronchiolitis ObliteransDrug: Seretide;Drug: PlaceboAssistance Publique - Hôpitaux de ParisGlaxoSmithKlineRecruiting6 Years17 YearsAll243Phase 3France
2NCT01307462
(ClinicalTrials.gov)
June 20111/3/2011Targeted Therapy of Bronchiolitis Obliterans SyndromeFluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell TransplantBronchiolitis ObliteransDrug: fluticasone propionate;Drug: montelukast sodium;Drug: azithromycinStephanie LeeNational Cancer Institute (NCI)Completed6 Years99 YearsAll36Phase 2United States