DDrare: Database of Drug Development for Rare Diseases

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	EUCTR2012-003331-32-BE (EUCTR)	18/06/2013	12/11/2012	A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION	A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION	EARLY 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;Classification code 10016547;Term: FEV;System Organ Class: 10022891 - Investigations MedDRA version: 14.1;Classification code 10050433;Term: Prophylaxis against lung transplant rejection;Classification code 10006414;Term: Bronchial biopsy abnormal;Classification code 10025041;Term: Lung biopsy abnormal;Classification code 10016549;Term: FEV 1 abnormal;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;Classification code 10049237;Term: Acute cellular rejection;System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1;Classification code 10066543;Term: Acute allograft rejection;Classification code 10039008;Term: Reversible airways obstruction NOS;Classification code 10019319;Term: Heart-lung transplant rejection;Level: LLTClassi;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Azithromycin (Zitromax°) Product Name: Zitromax Product Code: not applicable INN or Proposed INN: AZITHROMYCIN Other descriptive name: AZITHROMYCIN	KULeuven and University Hospitals Leuven	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 4	Belgium
2	EUCTR2010-018724-16-BE (EUCTR)	15/04/2010	07/04/2010	A prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tis	A prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tis	Lymphocytic 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;Classification code 10025041;Term: Lung biopsy abnormal MedDRA version: 12.1;Classification code 10063078;Term: Bronchoalveolar lavage abnormal MedDRA version: 12.1;Classification code 10049083;Term: Respiratory tract infection NOS MedDRA version: 12.1;Classification code 10016547;Term: FEV MedDRA version: 12.1;Classification code 10016549;Term: FEV 1 abnormal MedDRA version: 12.1;Classification code 10016550;Term: FEV 1 decreased MedDRA version: 12.1;Classification code 10016553;Term: FEV 1 low MedDRA version: 12.1;Classification code 10057799;Term: Computerised tomogram thorax abnormal MedDRA version: 12.1;Classification code 10025127;Term: Lung transplant MedDRA version: 12.1;Classification code 10056409;Term: Heart and lung transplant MedDRA version: 12.1;Classification code 10051604;Term: Lung transplant rejection MedDRA version: 12.1;Classification code 10019319;Term: Heart-lung transplant rejection MedDRA version: 12.1;Classification code 10029888;Term: Obliterative bronchiolitis MedDRA version: 12.1;Classification code 10049202;Term: Bronchiolitis obliterans MedDRA version: 12.1;Classification code 10050433;Term: Prophylaxis against lung transplant rejection MedDRA version: 12.1;Level: LLTClassification c	Trade Name: Zitromax Product Name: Zitromax Product Code: Na INN or Proposed INN: OTHER SOURCES Other descriptive name: AZITHROMYCIN DIHYDRATE	KULeuven and University Hospitals Leuven (Leuven Lung Transplant Group)	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 4	Belgium

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

EUCTR2012-003331-32-BE
(EUCTR)

18/06/2013

12/11/2012

A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION

EARLY 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;Classification code 10016547;Term: FEV;System Organ Class: 10022891 - Investigations
MedDRA version: 14.1;Classification code 10050433;Term: Prophylaxis against lung transplant rejection;Classification code 10006414;Term: Bronchial biopsy abnormal;Classification code 10025041;Term: Lung biopsy abnormal;Classification code 10016549;Term: FEV 1 abnormal;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;Classification code 10049237;Term: Acute cellular rejection;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1;Classification code 10066543;Term: Acute allograft rejection;Classification code 10039008;Term: Reversible airways obstruction NOS;Classification code 10019319;Term: Heart-lung transplant rejection;Level: LLTClassi;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Trade Name: Azithromycin (Zitromax°)
Product Name: Zitromax
Product Code: not applicable
INN or Proposed INN: AZITHROMYCIN
Other descriptive name: AZITHROMYCIN

KULeuven and University Hospitals Leuven

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Belgium

EUCTR2010-018724-16-BE
(EUCTR)

15/04/2010

07/04/2010

A prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tis

Lymphocytic 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;Classification code 10025041;Term: Lung biopsy abnormal
MedDRA version: 12.1;Classification code 10063078;Term: Bronchoalveolar lavage abnormal
MedDRA version: 12.1;Classification code 10049083;Term: Respiratory tract infection NOS
MedDRA version: 12.1;Classification code 10016547;Term: FEV
MedDRA version: 12.1;Classification code 10016549;Term: FEV 1 abnormal
MedDRA version: 12.1;Classification code 10016550;Term: FEV 1 decreased
MedDRA version: 12.1;Classification code 10016553;Term: FEV 1 low
MedDRA version: 12.1;Classification code 10057799;Term: Computerised tomogram thorax abnormal
MedDRA version: 12.1;Classification code 10025127;Term: Lung transplant
MedDRA version: 12.1;Classification code 10056409;Term: Heart and lung transplant
MedDRA version: 12.1;Classification code 10051604;Term: Lung transplant rejection
MedDRA version: 12.1;Classification code 10019319;Term: Heart-lung transplant rejection
MedDRA version: 12.1;Classification code 10029888;Term: Obliterative bronchiolitis
MedDRA version: 12.1;Classification code 10049202;Term: Bronchiolitis obliterans
MedDRA version: 12.1;Classification code 10050433;Term: Prophylaxis against lung transplant rejection
MedDRA version: 12.1;Level: LLTClassification c

Trade Name: Zitromax
Product Name: Zitromax
Product Code: Na
INN or Proposed INN: OTHER SOURCES
Other descriptive name: AZITHROMYCIN DIHYDRATE

KULeuven and University Hospitals Leuven (Leuven Lung Transplant Group)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Belgium