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 228. 閉塞性細気管支炎 [臨床試験数:57,薬物数:78(DrugBank:34),標的遺伝子数:33,標的パスウェイ数:32] 

Searched query = "Bronchiolitis obliterans", "Obliterating bronchiolitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Inclusion_
agemin
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PhaseCountries
1NCT04107675January 20207 October 2019A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell TransplantA Phase IIa Multi-Center, Randomized, Single-Blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell TransplantationBronchiolitis Obliterans;GVHD, Chronic;Stem Cell Transplant ComplicationsDrug: Liposomal Cyclosporine A;Drug: Liposomal PlaceboBreath Therapeutics Inc.Not recruiting18 YearsN/AAll24Phase 2
2NCT03283007October 20194 November 2019Nintedanib in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome Grade 1-2A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Transplant (LTx) Recipients With Bronchiolitis Obliterans Syndrome (BOS) Grade 1-2Lung-transplant RecipientsDrug: Nintedanib;Drug: PlaceboAssistance Publique - Hôpitaux de ParisRecruiting18 YearsN/AAll80Phase 3France
3NCT03978637September 9, 201922 October 2019Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung TransplantationAn Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung TransplantationBronchiolitis Obliterans SyndromeDrug: ItacitinibIncyte CorporationRecruiting18 YearsN/AAll75Phase 1/Phase 2United States
4NCT04029636August 201929 July 2019Hyperpolarized 129Xe MRI for the Assessment of BOS With Late Onset LONIPCHyperpolarized 129Xe Magnetic Resonance Imaging for the Early Detection of Bronchiolitis Obliterans Syndrome (BOS) and Other Late Onset Non-infectious Pulmonary Complications (LONIPCs) Following Hematopoietic Stem Cell TransplantationBronchiolitis ObliteransOther: Inhaled Hyperpolarized Xenon-129Hamilton Health Sciences CorporationNot recruiting18 Years70 YearsAll45N/ACanada
5NCT03603899June 201911 February 2019Hp129 Xenon Imaging and BOS in Lung TransplantationImaging and Understanding Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplantation With Hyperpolarized 129Xenon MR Lung ImagingBronchiolitis ObliteransDrug: Hp 129XenonChildren's Hospital Medical Center, CincinnatiNot recruiting6 YearsN/AAll45Phase 1/Phase 2United States
No.TrialIDDate_
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6NCT03674047April 19, 201913 May 2019Ruxolitinib for Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplantation (HCT)A Phase II Study of Ruxolitinib for Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplantation (HCT)Other CancerDrug: ruxolitinibMassachusetts General HospitalIncyte CorporationRecruiting18 Years75 YearsAll50Phase 2United States
7EUCTR2018-001747-31-FR09/04/201930 April 2019A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Transplant (LTx) recipients with bronchiolitis obliterans syndrome (BOS) grade 1-2A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Tranplant (LTx) recipients with bronchiolitis obliterans sydrome (BOS) grade 1-2 - INFINITX BOSBronchiolitis Obliterating Syndrome (SBO) grade 1 or 2 in patients with pulmonary transplantation.
MedDRA version: 20.0 Level: PT Classification code 10029888 Term: Obliterative bronchiolitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: OFEV
Pharmaceutical Form: Capsule
INN or Proposed INN: Nintedanib
Other descriptive name: Nintedanib
Concentration unit: mg milligram(s)
Concentration type: equal
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)Authorised Female: yes
Male: yes
80Phase 3France
8NCT03656926March 29, 201914 October 2019A Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A Inhalation Solution in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Double Lung TransplantA Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care Versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Double Lung TransplantationBronchiolitis Obliterans;Chronic Rejection of Lung Transplant;Lung Transplant Rejection;Lung Transplant; Complications;Lung Transplant Failure and RejectionDrug: Liposomal Cyclosporine ABreath Therapeutics Inc.Recruiting18 YearsN/AAll110Phase 3United States;Austria;Belgium;France;Germany;Israel;Spain;United Kingdom
9NCT03657342March 26, 201914 October 2019A Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A Inhalation Solution in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Single Lung TransplantA Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care Versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Single Lung TransplantationBronchiolitis Obliterans;Chronic Rejection of Lung Transplant;Lung Transplant Rejection;Lung Transplant; Complications;Lung Transplant Failure and RejectionDrug: Liposomal Cyclosporine ABreath Therapeutics Inc.Recruiting18 YearsN/AAll110Phase 3United States;France;Germany;Israel;Spain;United Kingdom
10NCT03805477March 20, 20198 April 2019Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell TransplantationNintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation (HSCT)- a Multicentre Phase II TrialBronchiolitis Obliterans Syndrome (BOS);Bronchiolitis Obliterans (BO)Drug: NintedanibUniversity Hospital, Basel, SwitzerlandRecruiting18 YearsN/AAll40Phase 2Austria;Germany;Switzerland
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
11EUCTR2018-003205-25-ES01/03/201930 April 2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after double lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation - BOSTON-2Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
Pharmaceutical Form: Powder and solvent for nebuliser solution
INN or Proposed INN: Ciclosporin (Ciclosporinium)
CAS Number: 59865-13-3
Current Sponsor code: L-CsA
Other descriptive name: CICLOSPORIN A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
BREATH Therapeutics Inc.Authorised Female: yes
Male: yes
110Phase 3France;United States;Belgium;Spain;Austria;Israel;Germany;United Kingdom
12EUCTR2018-003204-39-FR09/01/201928 February 2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after single lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation - BOSTON-1Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
Pharmaceutical Form: Powder and solvent for nebuliser solution
INN or Proposed INN: Ciclosporin (Ciclosporinium)
CAS Number: 59865-13-3
Current Sponsor code: L-CsA
Other descriptive name: CICLOSPORIN A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
BREATH Therapeutics Inc.Authorised Female: yes
Male: yes
130Phase 3United States;France;Spain;Israel;Germany;United Kingdom
13NCT03315741March 1, 201824 June 2019The Safety and Tolerability of Pirfenidone for BOS After HCTThe Safety and Tolerability of Pirfenidone for Bronchiolitis Obliterans Syndrome After Hematopoietic Cell TransplantationBronchiolitis Obliterans;Graft Vs Host DiseaseDrug: Pirfenidone 267 MG [Esbriet]Stanford UniversityGenentech, Inc.Recruiting18 YearsN/AAll30Phase 1United States
14NCT02669251April 28, 201611 November 2019Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell TransplantationA Phase 1b/2 Study of Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell TransplantationChronic Graft vs Host Disease;Chronic Graft-Versus-Host-Disease;Bronchiolitis Obliterans SyndromeDrug: MPH966National Cancer Institute (NCI)Recruiting18 Years99 YearsAll34Phase 1/Phase 2United States
15NCT02863835April 201611 June 2018Evaluation of Electrical Impedance Tomography for the Diagnosis of Chronic Rejection in Lung Transplants RecipientsEvaluation of Electrical Impedance Tomography for the Diagnosis of Chronic Rejection in Lung Transplants RecipientsTransplantation, Heart-Lung;Chronic Lung Allograft Dysfunction;Bronchiolitis Obliterans SyndromeOther: EIT;Other: Salbutamol nebulisation and with CPAPGuy's and St Thomas' NHS Foundation TrustADIR AssociationNot recruiting18 Years70 YearsAll50N/AUnited Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
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agemin
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PhaseCountries
16NCT02262299May 20159 September 2019European Trial of Pirfenidone in BOS, A European Multi-center StudyA European Multi-center, Randomised, Double-blind Trial of Pirfenidone in Bronchiolitis-obliterans-syndrome Grade 1-3 in Lung Transplant RecipientsDisorder Related to Lung Transplantation;CLAD, Bronchiolitis ObliteransDrug: Pirfenidone;Drug: PlaceboRigshospitalet, DenmarkNot recruiting18 YearsN/AAll90Phase 2/Phase 3Belgium;Denmark;Germany;Netherlands;Norway;Sweden;United Kingdom
17NCT03072849April 201516 December 2017Early Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell TransplantationEarly Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell TransplantationBronchiolitis Obliterans SyndromeProcedure: Pulmonary function testing;Drug: FAM TherapyAnn & Robert H Lurie Children's Hospital of ChicagoRecruiting6 Years18 YearsAll40N/AUnited States
18EUCTR2014-002022-12-BE10/03/20152 October 2017European Trial of Pirfenidone in BOS (EPOS).A European multi-centre, randomised, double-blind trial of pirfenidone in bronchiolitis-obliterans-syndrome grade 1-3 in lung transplant recipients. - EPOS TrialBronchiolitis Obliterans Syndrome (BOS) in patients following lung transplantation. This syndrome occurs due to rejection of the transplanted organ (s).
MedDRA version: 20.0 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans System Organ Class: 100000015490 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Pirfenidone
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PIRFENIDONE
CAS Number: 53179-13-8
Current Sponsor code: PIR
Other descriptive name: 5-Methyl-1-Phenyl-2-1-(H)-Pyridone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 267-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Clinical Trials Unit, RigshospitaletAuthorisedFemale: yes
Male: yes
80Phase 2Belgium;Denmark;Netherlands;Germany;United Kingdom;Sweden
19EUCTR2014-002022-12-GB06/01/201528 February 2019European Trial of Pirfenidone in BOS (EPOS).A European multi-centre, randomised, double-blind trial of pirfenidone in bronchiolitis-obliterans-syndrome grade 1-3 in lung transplant recipients. - EPOS TrialBronchiolitis Obliterans Syndrome (BOS) in patients following lung transplantation. This syndrome occurs due to rejection of the transplanted organ (s).
MedDRA version: 20.0 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Pirfenidone
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PIRFENIDONE
CAS Number: 53179-13-8
Current Sponsor code: PIR
Other descriptive name: 5-Methyl-1-Phenyl-2-1-(H)-Pyridone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 267-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Clinical Trials Unit, RigshospitaletAuthorised Female: yes
Male: yes
90Phase 2Belgium;Denmark;Netherlands;Germany;United Kingdom;Sweden
20NCT02316392December 201416 December 2017Imaging and Understanding BOS in Lung TransplantationImaging and Understanding BOS in Lung TransplantationBronchiolitis Obliterans SyndromeDrug: Hyperpolarized Helium-3 MRIChildren's Hospital Medical Center, CincinnatiNot recruiting1 Year25 YearsAll6N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT02543073September 201416 December 2017MSC for Treatment of Interstitial Lung Disease After Allo-HSCTMesenchymal Stem Cell for Treatment of Interstitial Lung Disease After Allogenetic Hematopoietic Stem Cell TransplantationLung Diseases, Interstitial;Hematopoietic Stem Cell Transplantation;Bronchiolitis ObliteransBiological: MSCs;Drug: AZM;Drug: GlucocorticoidNanfang Hospital of Southern Medical UniversitySun Yat-sen UniversityRecruiting18 Years65 YearsAll60Phase 1/Phase 2China
22NCT02181712July 20147 October 2019Mesenchymal Stem Cell Therapy for Lung RejectionA Pilot Study to Evaluate the Safety and Feasibility of Mesenchymal Stem Cells to Induce Remission in Lung Transplant Patients Experiencing Treatment-refractory Moderate to Severe Lung RejectionLung Transplant Reject;Bronchiolitis ObliteransBiological: Mesenchymal stem cell 0.5;Biological: Mesenchymal stem cell 1.0Mayo ClinicRecruiting18 Years75 YearsAll19Phase 1United States
23NCT01959100February 201420 August 2018Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell TransplantationEvaluation of the Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell TransplantationMalignant Hematological DiseasesDrug: Azithromycin;Drug: PlaceboAssistance Publique - Hôpitaux de ParisNot recruiting16 YearsN/AAll480Phase 3France
24EUCTR2013-000499-14-FR30/08/20138 May 2017N/AN/A - ALLOZITHROMedDRA version: 18.0 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans System Organ Class: 100000004855Trade Name: AZITHROMYCINE 250 mg
Product Name: AZITHROMYCINE 250 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: AZITHROMYCINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)Not RecruitingFemale: yes
Male: yes
Phase 3France
25EUCTR2012-003331-32-BE18/06/201311 June 2018A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATIONA PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATIONEARLY LUNG ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION
MedDRA version: 14.1 Level: LLT Classification code 10050437 Term: Prophylaxis against heart and lung transplant rejection System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1 Level: LLT Classification code 10016547 Term: FEV System Organ Class: 10022891 - Investigations
MedDRA version: 14.1 Level: LLT Classification code 10050433 Term: Prophylaxis against lung transplant rejection System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1 Level: LLT Classification code 10006414 Term: Bronchial biopsy abnormal System Organ Class: 10022891 - Investigations
MedDRA version: 14.1 Level: LLT Classification code 10025041 Term: Lung biopsy abnormal System Organ Class: 10022891 - Investigations
MedDRA version: 14.1 Level: LLT Classification code 10016549 Term: FEV 1 abnormal System Organ Class: 10022891 - Investigations
MedDRA version: 14.1 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1 Level: PT Classification code 10025127 Term: Lung transplant System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1 Level: LLT Classification code 10049237 Term: Acute cellular rejection System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1 Level: LLT Classification code 10066543 Term: Acute allograft rejection System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1 Level: LLT Classification code 10039008 Term: Reversible airways obstruction NOS System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1 Level: PT Classification code 10019319 Term: Heart-lung transplant rejection System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1 Level: LLT Classi;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Azithromycin (Zitromax°)
Product Name: Zitromax
Product Code: not applicable
Pharmaceutical Form: Syrup
INN or Proposed INN: AZITHROMYCIN
CAS Number: 83905-01-5
Current Sponsor code: AZI
Other descriptive name: AZITHROMYCIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
KULeuven and University Hospitals LeuvenNot RecruitingFemale: yes
Male: yes
60Phase 4Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
26NCT01469364March 201319 October 2017Safety Study of Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS)Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS) After Lung TransplantationComplication of Transplanted LungDrug: Aztreonam Lysine for Inhalation (AZLI);Procedure: Status Post Lung TransplantDuke UniversityGilead SciencesNot recruiting18 YearsN/AAll30Phase 4United States
27NCT01650545July 201211 June 2018Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant RecipientsA Pilot Study to Demonstrate Efficacy and Safety of Aerosol Liposomal Cyclosporine (L-CsA) in the Treatment of Bronchiolitis Obliterans Syndrome After Lung TransplantationDisorder Related to Lung Transplantation;Bronchiolitis Obliterans;Decreased Immunologic Activity;Chronic Rejection of Lung TransplantDrug: Liposomal aerosol cyclosporine;Other: standard immune suppression, oralUniversity of MarylandNot recruiting18 YearsN/AAll21Phase 1/Phase 2United States
28NCT01273207March 2, 20127 October 2019Extension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis ObliteransExtension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis ObliteransBronchiolitis Obliterans;Constructive Bronchiolitis;Graft Versus Host Disease;Bronchiolitis, Exudative;Bronchiolitis, Proliferative;Graft-Versus-Host DiseaseDrug: Cyclosporine Inhalation Solution (CIS)National Heart, Lung, and Blood Institute (NHLBI)Not recruiting10 Years80 YearsAll6Phase 2United States
29NCT01439958February 201228 April 2015Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)A Long-term Safety Follow-up Study of L-CsA Therapy for Patients Who Participated in Study 12011.201 and Volunteered to Continue or to Cross-over to L-CsA Inhalation TherapyBronchiolitis ObliteransDrug: InhalationPari Pharma GmbHNot recruiting18 Years80 YearsBoth14Phase 3Germany
30NCT01432080September 201116 December 2017Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post AllotransplantDoes Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot StudyRespiratory Tract Infections;Bronchiolitis Obliterans;Cryptogenic Organizing Pneumonia;Lung Diseases, InterstitialDrug: Prednisone;Drug: Azithromycin;Drug: Montelukast;Drug: SymbicortMaisonneuve-Rosemont HospitalThe Canadian Blood and Marrow Transplant GroupNot recruiting18 YearsN/AAll12Phase 2Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
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Inclusion_
gender
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size
PhaseCountries
31NCT01307462June 201116 December 2017Targeted 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)Not recruiting6 Years99 YearsAll36Phase 2United States
32NCT01327625March 201119 February 2015Efficacy Study of Azithromycin-based Therapy for Bronchiolitis ObliteransA Pilot Study Evaluating the Efficacy of Azithromycin, N-acetylcystein and Inhaled Corticosteroid Combination Therapy for Bronchiolitis Obliterans After Allogeneic Hematopoietic Cell TranspantationGraft vs Host Disease;Bronchiolitis ObliteransDrug: azithromycin + N-acetylcystein + inhaled corticosteroidAsan Medical CenterNot recruiting15 Years75 YearsBoth6N/AKorea, Republic of
33NCT01287078January 29, 201128 January 2019Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis ObliteransPhase II Trial of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for Treatment of Bronchiolitis ObliteransConstrictive Bronchiolitis;Bronchiolitis Obliterans;Graft vs Host Disease;Bronchiolitis, Exudative;Bronchiolitis, ProliferativeDrug: Cyclosporine Inhalation SolutionNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting10 Years80 YearsAll25Phase 2United States
34NCT01211509October 201016 March 2015Montelukast in Bronchiolitis Obliterans SyndromeA Randomized, Double Blind, Placebo Controlled Trial With Montelukast to Treat Bronchiolitis Obliterans Syndrome After Lung TransplantationBronchiolitis Obliterans;Lung Transplantation;Graft RejectionDrug: MontelukastUniversitaire Ziekenhuizen LeuvenKatholieke Universiteit LeuvenNot recruiting18 Years75 YearsBoth30Phase 4Belgium
35NCT01212406October 201023 November 2015Vitamin D in Bronchiolitis Obliterans SyndromeA Randomized Double Blind Placebo Controlled Trial With Vitamin D to Prevent Bronchiolitis Obliterans Syndrome After Lung TransplantationAllograft Rejection;Lung Transplantation;Bronchiolitis ObliteransDrug: Vitamin DUniversitaire Ziekenhuizen LeuvenKatholieke Universiteit LeuvenNot recruiting18 YearsN/ABoth100Phase 4Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
36EUCTR2010-021983-14-BE23/09/201019 March 2012A randomized placebo-controlled double blind study to treat BOS.A randomized placebo-controlled double blind study to treat BOS.-Mortality at 1 and 2 year post diagnosis of BOS -Infection rate during BOS -Evolution of pulmonary function after diagnosis of BOS
MedDRA version: 12.1 Level: LLT Classification code 10029888 Term: Obliterative bronchiolitis
MedDRA version: 12.1 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans
MedDRA version: 12.1 Level: LLT Classification code 10068805 Term: Follicular bronchiolitis
MedDRA version: 12.1 Level: LLT Classification code 10019319 Term: Heart-lung transplant rejection
MedDRA version: 12.1 Level: LLT Classification code 10025127 Term: Lung transplant
MedDRA version: 12.1 Level: LLT Classification code 10051604 Term: Lung transplant rejection
MedDRA version: 12.1 Level: LLT Classification code 10056409 Term: Heart and lung transplant
MedDRA version: 12.1 Level: LLT Classification code 10016547 Term: FEV
MedDRA version: 12.1 Level: LLT Classification code 10016549 Term: FEV 1 abnormal
MedDRA version: 12.1 Level: LLT Classification code 10016550 Term: FEV 1 decreased
MedDRA version: 12.1 Level: LLT Classification code 10016553 Term: FEV 1 low
Trade Name: Montelukast Teva
Product Name: montelukast teva
Product Code: NA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: MONTELUKAST SODIUM
CAS Number: 151767-02-1
Current Sponsor code: RVG100911
Other descriptive name: Singulair
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
UZ GasthuisbergAuthorisedFemale: yes
Male: yes
30Belgium
37EUCTR2010-022027-30-BE23/09/201019 March 2012A randomized placebo-controlled double blind study to prevent BOS - VIT001A randomized placebo-controlled double blind study to prevent BOS - VIT001A study to prevent the occurence of chronic rejection after lung transplantation. Other points of investigation include lung function evolution, rate of survival, BAL cellularity, infection rate, rate of acute rejection and reflux
MedDRA version: 12.1 Level: LLT Classification code 10029888 Term: Obliterative bronchiolitis
MedDRA version: 12.1 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans
MedDRA version: 12.1 Level: LLT Classification code 10068805 Term: Follicular bronchiolitis
MedDRA version: 12.1 Level: LLT Classification code 10019319 Term: Heart-lung transplant rejection
MedDRA version: 12.1 Level: LLT Classification code 10025127 Term: Lung transplant
MedDRA version: 12.1 Level: LLT Classification code 10050433 Term: Prophylaxis against lung transplant rejection
MedDRA version: 12.1 Level: LLT Classification code 10050437 Term: Prophylaxis against heart and lung transplant rejection
MedDRA version: 12.1 Level: LLT Classification code 10051604 Term: Lung transplant rejection
MedDRA version: 12.1 Level: LLT Classification code 10056409 Term: Heart and lung transplant
MedDRA version: 12.1 Level: LLT Classification code 10016547 Term: FEV
MedDRA version: 12.1 Level: LLT Classification code 10016549 Term: FEV 1 abnormal
MedDRA version: 12.1 Level: LLT Classification code 10016550 Term: FEV 1 decreased
MedDRA version: 12.1 Level: LLT Classification code 10016553 Term: FEV 1 low
Trade Name: D-Cure
Product Name: D-cure
Pharmaceutical Form: Oral solution
INN or Proposed INN: COLECALCIFEROL
CAS Number: 67-97-0
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 25000-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
UZ GasthuisbergAuthorisedFemale: yes
Male: yes
Belgium
38NCT01163786July 201023 April 2019A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHDA Phase 2 Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHDBronchiolitis ObliteransDrug: BortezomibNorthwestern UniversityRobert H. Lurie Cancer CenterNot recruitingN/AN/AAll20Phase 2United States
39EUCTR2010-018724-16-BE15/04/201021 August 2017A prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tisA prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tisLymphocytic airway inflammation (so-called Lymphocytic Bronchitis or Bronchiolitis) post-lung transplantation: evolution of airway inflammation (BAL, TBB), pulmonary function, radiology after 3 months, 6 months, 12 months and outcome 2 years (mortality, bronchiolitis obliterans syndrome) after treatment for histologic confirmed lymphocytic bronchi(oli)tis without concurrent acute allograft rejection.
MedDRA version: 12.1 Level: LLT Classification code 10006414 Term: Bronchial biopsy abnormal
MedDRA version: 12.1 Level: LLT Classification code 10025041 Term: Lung biopsy abnormal
MedDRA version: 12.1 Level: LLT Classification code 10063078 Term: Bronchoalveolar lavage abnormal
MedDRA version: 12.1 Level: LLT Classification code 10049083 Term: Respiratory tract infection NOS
MedDRA version: 12.1 Level: LLT Classification code 10016547 Term: FEV
MedDRA version: 12.1 Level: LLT Classification code 10016549 Term: FEV 1 abnormal
MedDRA version: 12.1 Level: LLT Classification code 10016550 Term: FEV 1 decreased
MedDRA version: 12.1 Level: LLT Classification code 10016553 Term: FEV 1 low
MedDRA version: 12.1 Level: LLT Classification code 10057799 Term: Computerised tomogram thorax abnormal
MedDRA version: 12.1 Level: LLT Classification code 10025127 Term: Lung transplant
MedDRA version: 12.1 Level: LLT Classification code 10056409 Term: Heart and lung transplant
MedDRA version: 12.1 Level: LLT Classification code 10051604 Term: Lung transplant rejection
MedDRA version: 12.1 Level: LLT Classification code 10019319 Term: Heart-lung transplant rejection
MedDRA version: 12.1 Level: LLT Classification code 10029888 Term: Obliterative bronchiolitis
MedDRA version: 12.1 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans
MedDRA version: 12.1 Level: LLT Classification code 10050433 Term: Prophylaxis against lung transplant rejection
MedDRA version: 12.1 Level: LLT Classification c
Trade Name: Zitromax
Product Name: Zitromax
Product Code: Na
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: OTHER SOURCES
CAS Number: 117772700
Current Sponsor code: ZTM250
Other descriptive name: AZITHROMYCIN DIHYDRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-250
KULeuven and University Hospitals Leuven (Leuven Lung Transplant Group)Not RecruitingFemale: yes
Male: yes
20Phase 4Belgium
40EUCTR2010-022467-36-DE7 April 2015A phase II study about interferon gamma 1b to therapy the steroid-refractory bronchiolitis obliterans after allogenic stem cell therapyA phase II study about interferon gamma 1b to therapy the steroid-refractory bronchiolitis obliterans after allogenic stem cell therapysteroid-refractory bronchiolitis obliterans
MedDRA version: 13.1 Level: PT Classification code 10029888 Term: Obliterative bronchiolitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Imukin
Product Name: Imukin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon gamma-1b
CAS Number: 98059-61-1
Current Sponsor code: Imukin
Other descriptive name: INTERFERON GAMMA-1B
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0,1-
Freistaat BayernNot RecruitingFemale: yes
Male: yes
Phase 2Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2005-003893-46-BE03/11/20097 October 2014AZITHROMYCIN IN BRONCHIOLITIS OBLITERANS SYNDROME - AZI001AZITHROMYCIN IN BRONCHIOLITIS OBLITERANS SYNDROME - AZI001- Chronic rejection at 1 and 2 year post-lung transplantation - Mortality at 1 and 2 year post-lung transplantation - Acute rejection rate at 1 and 2 post-lung transplantation - Infection rate at 1 and 2 year post-lung transplantation - Evolution of airway inflammation and pulmonary function during the first and second year post-lung transplantation
MedDRA version: 12.0 Level: LLT Classification code 10029888 Term: Obliterative bronchiolitis
MedDRA version: 12.0 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans
MedDRA version: 12.0 Level: LLT Classification code 10068805 Term: Follicular bronchiolitis
MedDRA version: 12.0 Level: LLT Classification code 10019319 Term: Heart-lung transplant rejection
MedDRA version: 12.0 Level: LLT Classification code 10025127 Term: Lung transplant
MedDRA version: 12.0 Level: LLT Classification code 10050433 Term: Prophylaxis against lung transplant rejection
MedDRA version: 12.0 Level: LLT Classification code 10050437 Term: Prophylaxis against heart and lung transplant rejection
MedDRA version: 12.0 Level: LLT Classification code 10051604 Term: Lung transplant rejection
MedDRA version: 12.0 Level: LLT Classification code 10056409 Term: Heart and lung transplant
MedDRA version: 12.0 Level: LLT Classification code 10016547 Term: FEV
MedDRA version: 12.0 Level: LLT Classification code 10016549 Term: FEV 1 abnormal
MedDRA version: 12.0 Level: LLT Classification code 10016550 Term: FEV 1 decreased
MedDRA version: 12.0 Level: LLT Classification code 10016553 Term: FEV 1 low
Trade Name: Zithromax
Product Name: Zithromax
Product Code: NA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: AZITHROMYCIN DIHYDRATE
CAS Number: 117772700
Current Sponsor code: ZTM 250
Other descriptive name: AZITHROMYCIN DIHYDRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
KULeuven and University Hospitals Leuven (Leuven Lung Transplant Group)Not RecruitingFemale: yes
Male: yes
80Belgium
42EUCTR2008-003801-15-GB26/02/200914 August 2012A phase II, randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in the treatment of bronchiolitis obliterans syndrome (BOS) in allogeneic haematopoietic stem cell transplant (HSCT) patientsA phase II, randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in the treatment of bronchiolitis obliterans syndrome (BOS) in allogeneic haematopoietic stem cell transplant (HSCT) patientsBronchiolitis Obliterans Syndrome
MedDRA version: 9.1 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
Pharmaceutical Form: Powder for nebuliser solution
INN or Proposed INN: Ciclosporin
CAS Number: 59865-13-3
Current Sponsor code: 081400
Other descriptive name: Ciclosporine, ciclosporina
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Powder for nebuliser solution
Route of administration of the placebo: Inhalation use
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride solvent
Pharmaceutical Form: Nebuliser solution
Current Sponsor code: Sodium Chloride
Other descriptive name: Sodium Chloride
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.25-
PARIPharma GmbHNot RecruitingFemale: yes
Male: yes
70Phase 2United Kingdom
43NCT00755781September 200819 February 2015Study of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung TransplantationA Multi-Center, Randomized, Controlled Study to Demonstrate the Efficacy and Safety of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung TransplantationLung TransplantDrug: Cyclosporine Inhalation Solution (CIS)APT Pharmaceuticals, Inc.Not recruiting18 YearsN/ABoth284Phase 3United States;Canada
44NCT00656058June 17, 200811 June 2018Montelukast to Treat Bronchiolitis ObliteransMulti-Institutional Prospective Phase II Study of Montelukast for the Treatment of Bronchiolitis Obliterans Following Allogeneic or Autologous Stem Cell Transplantation in Children and AdultsBronchiolitis Obliterans;Chronic Graft Versus Host Disease;Leukotriene;Montelukast;Stem Cell TransplantDrug: Singulair (Montelukast Sodium)National Cancer Institute (NCI)Not recruiting6 Years80 YearsAll25Phase 2United States
45NCT01560689June 200819 February 2015Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell TransplantationOpen-labeled Trial to Evaluate the Therapeutic Effects of Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans After Allogeneic Stem Cell TransplantationBronchiolitis Obliterans;Allogeneic Stem Cell TransplantationDrug: Budesonide/formoterol;Drug: PlaceboAssistance Publique - Hôpitaux de ParisNot recruiting16 YearsN/ABoth32Phase 2France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT00624754March 200819 February 2015Prospective Evaluation of the Efficacy of Budesonide/Formoterol in Bronchiolitis Obliterans in AHSCTrecipientsProspective Evaluation of the Efficacy of Budesonide/Formoterol (Symbicort®) in Bronchiolitis Obliterans in Allogeneic Haematopoietic Stem Cell Transplantation (AHSCT) RecipientsObstructive Airway DiseaseDrug: Formoterol/Budesonide;Drug: lactoseAssistance Publique - Hôpitaux de ParisAstraZenecaNot recruiting16 YearsN/ABoth32Phase 2France
47EUCTR2008-003801-15-BE2 October 2017A phase II, randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in the treatment of bronchiolitis obliterans syndrome (BOS) in allogeneic haematopoietic stem cell transplant (HSCT) patientsA phase II, randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in the treatment of bronchiolitis obliterans syndrome (BOS) in allogeneic haematopoietic stem cell transplant (HSCT) patientsBronchiolitis Obliterans Syndrome
MedDRA version: 9.1 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
Pharmaceutical Form: Powder for nebuliser solution
INN or Proposed INN: Ciclosporin
CAS Number: 59865-13-3
Current Sponsor code: 081400
Other descriptive name: Ciclosporine, ciclosporina
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Powder for nebuliser solution
Route of administration of the placebo: Inhalation use
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride solvent
Pharmaceutical Form: Nebuliser solution
Current Sponsor code: Sodium Chloride
Other descriptive name: Sodium Chloride
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.25-
PARIPharma GmbHNot RecruitingFemale: yes
Male: yes
70Phase 2Belgium;United Kingdom
48NCT00378677February 200719 February 2015Dry Powder Inhalation of Cyclosporine A in Lung Transplant Patients With Bronchiolitis Obliterans SyndromePilot Study of Cyclosporine A Dry Powder Inhalation in Lung Transplant Patients With Bronchiolitis Obliterans SyndromeLung Transplantation;Bronchiolitis ObliteransDrug: Cyclosporine A dry powder inhalation (Drug)University Medical Centre GroningenRecruiting18 YearsN/ABoth7Phase 0Netherlands
49NCT00367419November 200619 February 2015Use of Erythromycin in Mustard-Induced BronchiolitisLow-Dose Long-Term Prescription of Erythromycin in Mustard-Induced Bronchiolitis ObliteransBronchiolitis Obliterans;Acute Obliterating BronchiolitisDrug: ErythromycinBaqiyatallah Medical Sciences UniversityNot recruitingN/AN/AMalePhase 4Iran, Islamic Republic of
50EUCTR2006-000485-36-GB23/08/200614 August 2012A randomised, double blind, placebo controlled study to Assess The Effect of Antibiotic Therapy on Chronic Rejection in Human Lung Transplantation - Azithromycin StudyA randomised, double blind, placebo controlled study to Assess The Effect of Antibiotic Therapy on Chronic Rejection in Human Lung Transplantation - Azithromycin StudyPost Lung Transplantation Chronic Rejection identified as bronchiolitis obliterans syndrome (BOS)Product Name: Azithromycin
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Newcastle upon Tyne Hospitals NHS TrustNot RecruitingFemale: yes
Male: yes
64United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2004-001290-25-GB14/09/200515 July 2013A 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. - CeMyLungA 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. - CeMyLungHeart-Lung, bilateral lung and single lung transplant recipients ICD Classification: K01-K01.9, E53.9+Z94.1, E53.9+Z94.2, E53.9+Z94.3Trade Name: Certican
Pharmaceutical Form: Tablet
Trade Name: Myfortic
Pharmaceutical Form: Tablet
St Vincent's HospitalNot RecruitingFemale: yes
Male: yes
320Spain;Austria;Germany;United Kingdom
52NCT00563251April 200519 February 2015Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow TransplantationAzithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow TransplantationBronchiolitis Obliterans;Bone Marrow TransplantationDrug: Azithromycin;Drug: Placebo tabletHospital Authority, Hong KongThe University of Hong Kong;PfizerNot recruiting18 YearsN/ABoth30N/AChina
53NCT00188825May 200416 December 2017Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung TransplantA Randomized, Double Blind, Placebo Controlled Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans Syndrome in Bilateral Lung and Single Lung Transplant PatientsCOPD;Emphysema;Alpha-1 Antitrypsan DeficiencyOther: placebo;Drug: basiliximabUniversity Health Network, TorontoNovartisNot recruiting18 Years65 YearsAll22Phase 3Canada
54NCT00141726October 200319 October 2017Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell TransplantSoluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II StudyLung Injury, Acute;Respiratory Distress Syndrome, Adult;Bronchiolitis ObliteransDrug: EtanerceptUniversity of Michigan Cancer CenterNot recruiting6 YearsN/AAll34Phase 2United States
55NCT00381147July 200319 February 2015Use of Clarithromycin in Mustard-Induced BronchiolitisPhase III, Randomized, Double Blind Study of Low Dose Long Term Clarithromycin Versus Placebo in Treatment of Chronic Pulmonary Lesions Due to Sulfur MustardBronchiolitis Obliterans;Acute Obliterating BronchiolitisDrug: ClarithromycinBaqiyatallah Medical Sciences UniversityNot recruitingN/AN/AMalePhase 3Iran, Islamic Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
agemax
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Target_
size
PhaseCountries
56NCT00029328September 20017 April 2015Etanercept for Non-Infectious Lung Injury Following Bone Marrow TransplantationSoluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell TransplantationRespiratory Distress Syndrome, Adult;Bronchiolitis Obliterans;PneumoniaDrug: etanerceptFDA Office of Orphan Products DevelopmentNot recruiting12 MonthsN/ABoth15Phase 1/Phase 2United States
57NCT01429844January 200119 February 2015Tacrolimus Versus Cyclosporine for Immunosuppression After Lung TransplantationRandomized, Open-label, Multi-Center Study Comparing Tacrolimus With Cyclosporin, Both Arms in Combination With Mycophenolate Mofetil and Corticosteroids for Prevention of Bronchiolitis Obliterans Syndrome in Lung Transplant PatientsBronchiolitis Obliterans;ImmunosuppressionDrug: Tacrolimus;Drug: CyclosporineUniversitätsklinikum Hamburg-EppendorfNot recruiting18 Years66 YearsBoth274Phase 3Australia;Austria;Belgium;Germany;Spain;Switzerland

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