DDrare: Database of Drug Development for Rare Diseases

228. 閉塞性細気管支炎
［臨床試験数：92，薬物数：125（DrugBank：34），標的遺伝子数：33，標的パスウェイ数：152］

Searched query = "Bronchiolitis obliterans", "Obliterating bronchiolitis"
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.

Drug = 5-Methyl-1-Phenyl-2-1-(H)-Pyridone; AZITHROMYCIN; AZITHROMYCIN DIHYDRATE; AZITHROMYCINE; AZITHROMYCINE 250 mg; AZM; Adipate; Aerolised Liposomal Ciclosporin A; Aerolised Liposomal Ciclosporin A 10mg; Aerolised Liposomal Ciclosporin A 5mg; Azithromycin; Azithromycin (Zitromax°); Azithromycin + N-acetylcystein + inhaled corticosteroid; Azithromycine; Aztreonam; Aztreonam Lysine for Inhalation (AZLI); Basiliximab; Bortezomib; Budesonide; Budesonide/formoterol; CICLOSPORIN A; COLECALCIFEROL; Certican; Certican 0,5; Certican 0,5 mg Tabletten; Certican 0,75mg; Certican 0,75mg Tabletten; Chloride; Ciclosporin; Ciclosporin (Ciclosporinium); Ciclosporina; Ciclosporina / Ciclosporin; Ciclosporina A Liposomica Aerolised Liposomal Ciclosporin A; Ciclosporina/ Ciclosporin; Ciclosporine; Ciclosporine A; Ciclosporine, Ciclosporina; Ciclosporine, ciclosporina; Clarithromycin; Cloruro de Sodio; Cloruro de sodio; Colecalciferol; CsA; Cyclosporine; Cyclosporine A dry powder inhalation (Drug); Cyclosporine Inhalation Solution; Cyclosporine Inhalation Solution (CIS); D-Cure; D-cure; ERL080; Enteric coated mycophenolate sodium; Erythromycin; Esbriet; Etanercept; Everolimus; FAM Therapy; Fluticasone; Fluticasone propionate; Formoterol; Formoterol/Budesonide; Glucocorticoid; Helium; Helium-3; Hp 129Xenon; Hyperpolarized Helium-3 MRI; INTERFERON GAMMA-1B; Imukin; Inhalation; Interferon Gamma; Interferon gamma 1b; Interferon gamma-1b; Itacitinib; Itacitinib Adipate; L-CsA; Lactose; Liposomal Cyclosporine A; Liposomal Cyclosporine A 10 mg; Liposomal Cyclosporine A 5 mg; Liposomal aerosol cyclosporine; Lysine; MONTELUKAST SODIUM; MPH966; MSCs; Mesenchymal stem cell 0.5; Mesenchymal stem cell 1.0; Montelukast; Montelukast Teva; Montelukast sodium; Montelukast teva; Mycophenolate; Myfortic; Nintedanib; OFEV; OTHER SOURCES; Other: EIT; Other: Inhaled Hyperpolarized Xenon-129; Other: Salbutamol nebulisation and with CPAP; Other: standard immune suppression, oral; PIRFENIDONE; Pirfenidone; Pirfenidone 267 MG [Esbriet]; Prednisone; Procedure: Pulmonary function testing; Procedure: Status Post Lung Transplant; RAD001; Ruxolitinib; Salbutamol; Seretide; Singulair; Singulair (Montelukast Sodium); Sodium Chloride; Sodium Chloride Solution; Sodium Chloride Solvent; Sodium Chloride solvent; Sodium chloride; Solucion de Cloruro de Sodio; Solucion de cloruro de sodio Sodium Chloride Solution; Solvente Cloruro de Sodio Sodium Chloride Solvent; Solvente de Cloruro de Sodio; Symbicort; Tacrolimus; Vitamin D; Xenon; Zithromax; Zitromax

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	EUCTR2011-004304-38-ES (EUCTR)	19/09/2012	22/06/2012	An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA	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 therapy - Not applicable	Prevention of Bronchiolitis Obliterans Syndrome in lung transplant MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Aerolised Liposomal Ciclosporin A 5mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A 10mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina	PARI Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	180		France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
2	EUCTR2011-004304-38-GB (EUCTR)	14/06/2012	09/12/2011	An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA	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 therapy - Not applicable	Prevention of Bronchiolitis Obliterans Syndrome in lung transplant MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Aerolised Liposomal Ciclosporin A 5mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A 10mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina	PARI Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
3	EUCTR2011-004304-38-AT (EUCTR)	13/03/2012	20/12/2011	An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA	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 therapy	Prevention of Bronchiolitis Obliterans Syndrome in lung transplant MedDRA version: 15.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Aerolised Liposomal Ciclosporin A 5mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A 10mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina	PARI Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	180		France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
4	EUCTR2011-004304-38-BE (EUCTR)	14/02/2012	15/12/2011	An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA	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 therapy - Not applicable	Prevention of Bronchiolitis Obliterans Syndrome in lung transplant MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Aerolised Liposomal Ciclosporin A 5mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A 10mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina	PARI Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	France;Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom
5	EUCTR2011-004304-38-DK (EUCTR)	20/01/2012	19/12/2011	An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA	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 therapy - Not applicable	Prevention of Bronchiolitis Obliterans Syndrome in lung transplant MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Aerolised Liposomal Ciclosporin A 5mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A 10mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina	PARI Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	France;Canada;Belgium;Spain;Austria;Denmark;Germany;United Kingdom
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
6	EUCTR2011-004304-38-DE (EUCTR)	06/01/2012	28/11/2011	An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA	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 therapy	Prevention of Bronchiolitis Obliterans Syndrome in lung transplant MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Aerolised Liposomal Ciclosporin A 5mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A 10mg Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina	PARI Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	40		France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
7	EUCTR2008-003800-73-BE (EUCTR)	14/09/2010	08/01/2009	A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patients	A phase III, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients	Prevention of bronchiolitis obliterans syndrome in lung transplant MedDRA version: 15.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride	PARI Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom
8	EUCTR2008-003800-73-ES (EUCTR)	22/07/2010	26/05/2010	A phase II, multicentre,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 aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsEnsayo clínico de fase II, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y búsqueda de dosis para investigar la eficacia y la seguridad de 10 y 20 mg/día de Ciclosporina A Liposómica aerosolizada (L-CsA) frente a placebo aerosolizado en la prevención del síndrome de bronquiolitis obliterante (SBO) en pacientes con trasplante pulmonar	A phase II, multicentre,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 aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsEnsayo clínico de fase II, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y búsqueda de dosis para investigar la eficacia y la seguridad de 10 y 20 mg/día de Ciclosporina A Liposómica aerosolizada (L-CsA) frente a placebo aerosolizado en la prevención del síndrome de bronquiolitis obliterante (SBO) en pacientes con trasplante pulmonar	Prevention of bronchiolitis obliterans syndrome in lung transplantPrevención del sindrome de bronquiolitis obliterante en transplante pulmonar MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans	Product Name: Ciclosporina A Liposomica Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporina / Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Ciclosporina A Liposomica Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporina / Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Solucion de cloruro de sodio Sodium Chloride Solution Product Code: Solvente Cloruro de Sodio Sodium Chloride Solvent Other descriptive name: Cloruro de sodio Product Name: Solucion de Cloruro de Sodio Product Code: Solvente de Cloruro de Sodio Other descriptive name: Cloruro de Sodio	Pari Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	134	Phase 2	Belgium;Spain;Denmark;Austria;Germany;United Kingdom
9	EUCTR2008-003800-73-DK (EUCTR)	13/04/2010	18/08/2009	A phase II, multicentre,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 aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients	A phase II, multicentre,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 aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients	Prevention of bronchiolitis obliterans syndrome in lung transplant MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans	Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride	Pari Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	134	Phase 2	Spain;Belgium;Austria;Denmark;Germany;United Kingdom
10	EUCTR2008-003800-73-DE (EUCTR)	14/07/2009	29/12/2008	A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patients	A phase II, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients	Prevention of bronchiolitis obliterans syndrome in lung transplant MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride	PARI Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
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
11	EUCTR2008-003800-73-AT (EUCTR)	08/07/2009	11/05/2009	A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patients	A phase III, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients	Prevention of bronchiolitis obliterans syndrome in lung transplant MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , Ciclosporina Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride Product Name: Sodium Chloride Solution Product Code: Sodium Chloride Solvent Other descriptive name: Sodium Chloride	PARI Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom
12	EUCTR2008-003801-15-GB (EUCTR)	26/02/2009	24/11/2010	A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients	A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients	Bronchiolitis Obliterans Syndrome MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans	Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , ciclosporina Product Name: Sodium Chloride Solution Product Code: Sodium Chloride solvent Other descriptive name: Sodium Chloride	PARIPharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2	United Kingdom
13	EUCTR2004-001290-25-DE (EUCTR)	17/08/2006	17/05/2006	A 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. - CeMyLungs	A 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. - CeMyLungs	Heart-lung, bilateral lung and single lung transplant recipientsMain ICD Classification Codes:J84.1, J43-44, E84.0, Z94.2	INN or Proposed INN: Everolimus INN or Proposed INN: Everolimus INN or Proposed INN: Enteric coated mycophenolate sodium INN or Proposed INN: Ciclosporine A INN or Proposed INN: Ciclosporine A INN or Proposed INN: Ciclosporine A	St Vincent’s Hospital, Sydney, Australia	NULL	Not Recruiting			Female: yes Male: yes	320		United Kingdom;Germany;Spain
14	EUCTR2008-003801-15-BE (EUCTR)		08/01/2009	A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients	A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients	Bronchiolitis Obliterans Syndrome MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans	Product Name: Aerolised Liposomal Ciclosporin A Product Code: L-CsA INN or Proposed INN: Ciclosporin Other descriptive name: Ciclosporine , ciclosporina Product Name: Sodium Chloride Solution Product Code: Sodium Chloride solvent Other descriptive name: Sodium Chloride	PARIPharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2	Belgium;United Kingdom

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

EUCTR2011-004304-38-ES
(EUCTR)

19/09/2012

22/06/2012

An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA

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 therapy - Not applicable

Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine , Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine , Ciclosporina

PARI Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom

EUCTR2011-004304-38-GB
(EUCTR)

14/06/2012

09/12/2011

An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA

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 therapy - Not applicable

Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

PARI Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom

EUCTR2011-004304-38-AT
(EUCTR)

13/03/2012

20/12/2011

An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA

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 therapy

Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 15.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

PARI Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom

EUCTR2011-004304-38-BE
(EUCTR)

14/02/2012

15/12/2011

An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA

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 therapy - Not applicable

PARI Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

France;Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom

EUCTR2011-004304-38-DK
(EUCTR)

20/01/2012

19/12/2011

An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA

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 therapy - Not applicable

PARI Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

France;Canada;Belgium;Spain;Austria;Denmark;Germany;United Kingdom

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

EUCTR2011-004304-38-DE
(EUCTR)

06/01/2012

28/11/2011

An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA

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 therapy

PARI Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom

EUCTR2008-003800-73-BE
(EUCTR)

14/09/2010

08/01/2009

A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patients

A phase III, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients

Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 15.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

PARI Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3

Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom

EUCTR2008-003800-73-ES
(EUCTR)

22/07/2010

26/05/2010

A phase II, multicentre,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 aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsEnsayo clínico de fase II, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y búsqueda de dosis para investigar la eficacia y la seguridad de 10 y 20 mg/día de Ciclosporina A Liposómica aerosolizada (L-CsA) frente a placebo aerosolizado en la prevención del síndrome de bronquiolitis obliterante (SBO) en pacientes con trasplante pulmonar

Prevention of bronchiolitis obliterans syndrome in lung transplantPrevención del sindrome de bronquiolitis obliterante en transplante pulmonar
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans

Product Name: Ciclosporina A Liposomica Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporina / Ciclosporin
Other descriptive name: Ciclosporine , Ciclosporina
Product Name: Ciclosporina A Liposomica Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporina / Ciclosporin
Other descriptive name: Ciclosporine , Ciclosporina
Product Name: Solucion de cloruro de sodio Sodium Chloride Solution
Product Code: Solvente Cloruro de Sodio Sodium Chloride Solvent
Other descriptive name: Cloruro de sodio
Product Name: Solucion de Cloruro de Sodio
Product Code: Solvente de Cloruro de Sodio
Other descriptive name: Cloruro de Sodio

Pari Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

134

Phase 2

Belgium;Spain;Denmark;Austria;Germany;United Kingdom

EUCTR2008-003800-73-DK
(EUCTR)

13/04/2010

18/08/2009

Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans

Pari Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

134

Phase 2

Spain;Belgium;Austria;Denmark;Germany;United Kingdom

EUCTR2008-003800-73-DE
(EUCTR)

14/07/2009

29/12/2008

A phase II, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients

Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

PARI Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom

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

EUCTR2008-003800-73-AT
(EUCTR)

08/07/2009

11/05/2009

Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine , Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine , Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine , Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine , Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride

PARI Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3

Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom

EUCTR2008-003801-15-GB
(EUCTR)

26/02/2009

24/11/2010

A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients

Bronchiolitis Obliterans Syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans

Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine , ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride solvent
Other descriptive name: Sodium Chloride

PARIPharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

EUCTR2004-001290-25-DE
(EUCTR)

17/08/2006

17/05/2006

A 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. - CeMyLungs

Heart-lung, bilateral lung and single lung transplant recipientsMain ICD Classification Codes:J84.1, J43-44, E84.0, Z94.2

INN or Proposed INN: Everolimus
INN or Proposed INN: Everolimus
INN or Proposed INN: Enteric coated mycophenolate sodium
INN or Proposed INN: Ciclosporine A
INN or Proposed INN: Ciclosporine A
INN or Proposed INN: Ciclosporine A

St Vincent’s Hospital, Sydney, Australia

NULL

Not Recruiting

Female: yes
Male: yes

320

United Kingdom;Germany;Spain

EUCTR2008-003801-15-BE
(EUCTR)

08/01/2009

Bronchiolitis Obliterans Syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans

PARIPharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belgium;United Kingdom