| 1 |
NCT02458274 |
Recruiting |
Microparticles and Bronchiolitis Obliterans Syndrome |
|
- Other: Dosage of Microparticles (MPs) in broncho-alveolar lavage fluid (BALF)
|
Observational
|
|
- University Hospital, Strasbourg, France
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Correlation between total concentration of MPs in broncho-alveolar lavage fluid (BALF) and occurrence of bronchiolitis obliterans syndrome at three year post lung transplantation
- Total concentration MPs and characterization of cellular origin of MPs in BALF and in plasma of patients at three year post lung transplantation.
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT02458274 |
5254 |
MIBO |
July 2014 |
January 2020 |
January 2020 |
June 1, 2015 |
August 27, 2018 |
|
- CHU Strasbourg
Strasbourg, France
|
|
| 2 |
NCT03657342 |
Not yet recruiting |
A 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 Transplant |
|
- Drug: Liposomal Cyclosporine A
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mean change in FEV1 (mL) from baseline to Week 48
- Mean change in FEV1/FVC from baseline to Week 48
- Time to Progression of BOS
|
110 |
All |
18 Years and older (Adult, Older Adult) |
NCT03657342 |
BT - L-CsA - 301 - SLT |
BOSTON-1 |
March 2019 |
December 2021 |
January 2022 |
September 5, 2018 |
February 6, 2019 |
|
- St. Joseph's Hospital
Phoenix, Arizona, United States - UCLA Medical Center
Los Angeles, California, United States - Stanford University Hospital
Palo Alto, California, United States - (and 29 more...)
|
|
| 3 |
NCT03656926 |
Not yet recruiting |
A 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 Transplant |
|
- Drug: Liposomal Cyclosporine A
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mean change in FEV1 (mL) from baseline to Week 48)
- Mean change in FEV1/FVC from baseline to Week 48
- Tiime to Progression of BOS
|
110 |
All |
18 Years and older (Adult, Older Adult) |
NCT03656926 |
BT - L-CsA - 302 - DLT |
BOSTON-2 |
March 2019 |
September 2021 |
October 2021 |
September 3, 2018 |
February 6, 2019 |
|
- St. Joseph's Hospital
Phoenix, Arizona, United States - UCLA Medical Center
Los Angeles, California, United States - Stanford University Hospital
Palo Alto, California, United States - (and 33 more...)
|
|
| 4 |
NCT03072849 |
Recruiting |
Early Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell Transplantation |
- Bronchiolitis Obliterans Syndrome
|
- Procedure: Pulmonary function testing
- Drug: FAM Therapy
|
Observational
|
|
- Ann & Robert H Lurie Children's Hospital of Chicago
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Lung function
- Survival
- Risk factor assessment
|
40 |
All |
6 Years to 18 Years (Child, Adult) |
NCT03072849 |
SCT 1214 BOS |
|
April 2015 |
April 2017 |
April 2019 |
March 7, 2017 |
March 7, 2017 |
|
- Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
|
|
| 5 |
NCT01307462 |
Completed
Has Results |
Targeted Therapy of Bronchiolitis Obliterans Syndrome |
|
- Drug: fluticasone propionate
- Drug: montelukast sodium
- Drug: azithromycin
|
Interventional
|
Phase 2 |
- Stephanie Lee
- National Cancer Institute (NCI)
- Fred Hutchinson Cancer Research Center
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Subjects Who Failed Treatment
- Number of Subjects Who Experienced Grade 3-5 SAEs Attributable to FAM and Number of Subjects Who Stopped FAM as a Result
- Number of Subjects Who Experienced Statistically Significant Changes in FVC, TLC, RV, DLCO
- (and 7 more...)
|
36 |
All |
6 Years to 99 Years (Child, Adult, Older Adult) |
NCT01307462 |
2367.00
NCI-2011-00203
U54CA163438
RDCRN 6503 |
FAM for BOS |
June 2011 |
September 2014 |
December 2015 |
March 3, 2011 |
October 4, 2017 |
October 4, 2017 |
- Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States - Stanford University
Stanford, California, United States - H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States - (and 8 more...)
|
|
| 6 |
NCT01639261 |
Unknown † |
A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCT |
- Steroid-refractory Bronchiolitis Obliterans
|
- Drug: Interferon gamma 1b
|
Interventional
|
Phase 2 |
- University Hospital Regensburg
- ClinAssess GmbH
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
10 |
All |
18 Years and older (Adult, Older Adult) |
NCT01639261 |
IFN_BOSZT_01
2010-022467-36 |
IFN_BOSZT_01 |
July 2012 |
December 2013 |
September 2014 |
July 12, 2012 |
July 12, 2012 |
|
- University Hospital Regensburg
Regensburg, Germany
|
|
| 7 |
NCT01334892 |
Terminated |
L-CsA in the Prevention of Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplant (LT) Patients |
|
- Drug: Cyclosporine Inhalation Solution
|
Interventional
|
Phase 2
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- The primary objective is to compare cumulative BOS-free survival of patients recieving L-CsA or placebo.
- Cumulative mean incidence of BOS 12, 18 and 24 months after first IMP administration
|
130 |
All |
18 Years and older (Adult, Older Adult) |
NCT01334892 |
12011.201
2008-003800-73
ISRCTN66069132 |
|
December 2009 |
July 2013 |
December 2014 |
April 13, 2011 |
April 14, 2015 |
|
- PARI Pharma GmbH
Graefelfing, Germany
|
|
| 8 |
NCT01327248 |
Completed |
Clinical Status and Bronchial Inflammation in Patients With Bronchiolitis Obliterans |
|
|
Observational
|
|
- Johann Wolfgang Goethe University Hospital
|
Other |
- Observational Model: Case Control
- Time Perspective: Cross-Sectional
|
|
40 |
All |
6 Years to 25 Years (Child, Adult) |
NCT01327248 |
FRA-BO |
Frabo |
May 2011 |
May 2012 |
June 2012 |
April 1, 2011 |
June 27, 2012 |
|
- Children's Hospital, Goethe-University
Frankfurt am Main, Hessen, Germany
|
|
| 9 |
NCT00502554 |
Terminated |
Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation |
|
|
Interventional
|
Not Applicable |
- Hannover Medical School
- Mallinckrodt
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
12 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00502554 |
4584 |
|
August 2007 |
March 2010 |
March 2010 |
July 17, 2007 |
July 26, 2011 |
|
- Department Pneumology, Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany - Medizinische Hochschule Hannover, Dep. Pneumology
Hannover, Niedersachsen, Germany
|
|
| 10 |
NCT02181257 |
Active, not recruiting |
Extracorporeal Photopheresis for the Management of Progressive Bronchiolitis Obliterans Syndrome in Medicare-Eligible Recipients of Lung Allografts |
- Bronchiolitis Obliterans Syndrome (BOS)
|
|
Observational
|
|
- Washington University School of Medicine
- Centers for Medicare and Medicaid Services
- Mallinckrodt
|
Other / U.S. Fed / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in the rate of FEV1 decline assessed by comparing the average rate of FEV1 decline over the 6 months prior to ECP against the average rate of FEV1 decline over the 6 months following initiation of ECP
- Average rate of FEV1 decline over the 12 months following initiation of ECP
|
160 |
All |
18 Years and older (Adult, Older Adult) |
NCT02181257 |
CAG-00324R2 |
ECP Registry |
January 2015 |
July 2018 |
December 2018 |
July 3, 2014 |
December 19, 2017 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - University of California San Diego
La Jolla, California, United States - Indiana University Health
Indianapolis, Indiana, United States - (and 7 more...)
|
|
| 11 |
NCT03805477 |
Not yet recruiting |
Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation |
- Bronchiolitis Obliterans Syndrome (BOS)
- Bronchiolitis Obliterans (BO)
|
|
Interventional
|
Phase 2 |
- University Hospital, Basel, Switzerland
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- adverse event rate leading to interruption/ discontinuation of study treatment
- change of the percent of predicted forced expiratory volume in 1 second (FEV1)
- change in forced vital capacity (FVC)
- (and 12 more...)
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03805477 |
2018-00837; me17Hostettler |
NINBOST2018 |
February 2019 |
February 2021 |
February 2021 |
January 15, 2019 |
January 15, 2019 |
|
- University Hospital Graz
Graz, Austria - University Hospital Wien
Wien, Austria - Charité University Hospital
Berlin, Germany - (and 5 more...)
|
|
| 12 |
NCT00563251 |
Completed |
Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation |
- Bronchiolitis Obliterans
- Bone Marrow Transplantation
|
- Drug: Azithromycin
- Drug: Placebo tablet
|
Interventional
|
Not Applicable |
- Hospital Authority, Hong Kong
- The University of Hong Kong
- Pfizer
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Quality of life assessment by questionnaires
- Spirometry
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT00563251 |
UW 04-165 T/487
HARECCTR0500038 |
|
April 2005 |
|
March 2007 |
November 26, 2007 |
June 16, 2011 |
|
- Queen Mary Hospital
Hong Kong, China
|
|
| 13 |
NCT02902471 |
Completed |
Forced Oscillations for Diagnosis Help in Bronchiolitis Obliterans Syndrome in Post Bone Marrow Transplantation |
- Bronchiolitis Obliterans
- Bone Marrow Transplantation
|
- Other: Forced oscillations measure
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
|
110 |
All |
18 Years and older (Adult, Older Adult) |
NCT02902471 |
2010/48
2010-A01229-30 |
OSCILLOMOELL |
June 2011 |
September 2015 |
September 2015 |
September 15, 2016 |
July 16, 2018 |
|
- CHRU de Lille
Lille, France - Hopital Foch
Suresnes, France
|
|
| 14 |
NCT01560689 |
Completed |
Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation |
- Bronchiolitis Obliterans
- Allogeneic Stem Cell Transplantation
|
- Drug: Budesonide/formoterol
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- pulmonary function tests
- Dyspnea based on NYHA classification
- pulmonary function test
|
32 |
All |
16 Years and older (Child, Adult, Older Adult) |
NCT01560689 |
2 |
alloforb |
June 2008 |
July 2012 |
July 2012 |
March 22, 2012 |
September 7, 2012 |
|
- Hopital Saint Louis APHP
Paris, France
|
|
| 15 |
NCT00528853 |
Completed |
Correlation of Lung Biopsy, BAL, and High Resolution CT Scan in Lung Transplantation |
- Bronchiolitis Obliterans Syndrome
|
|
Observational
|
|
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
10 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00528853 |
15660A |
|
August 2007 |
December 2009 |
December 2009 |
September 12, 2007 |
August 19, 2016 |
|
- The University of Chicago Medical Center
Chicago, Illinois, United States
|
|
| 16 |
NCT03603899 |
Not yet recruiting |
Hp129 Xenon Imaging and BOS in Lung Transplantation |
|
|
Interventional
|
Phase 1
Phase 2 |
- Children's Hospital Medical Center, Cincinnati
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Capture 129Xe and proton MRI Images for clinician assessment
|
45 |
All |
6 Years and older (Child, Adult, Older Adult) |
NCT03603899 |
2017-4120 |
|
June 2019 |
July 2020 |
July 2021 |
July 27, 2018 |
February 1, 2019 |
|
- Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
|
|
| 17 |
NCT01327625 |
Terminated |
Efficacy Study of Azithromycin-based Therapy for Bronchiolitis Obliterans |
- Graft vs Host Disease
- Bronchiolitis Obliterans
|
- Drug: azithromycin + N-acetylcystein + inhaled corticosteroid
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response rate based on the improvement of FEV1
- Clinical benefit rate based on the degree of change in FEV1
- change in FEV1 compared with pretreatment level
- (and 5 more...)
|
6 |
All |
15 Years to 75 Years (Child, Adult, Older Adult) |
NCT01327625 |
AMC-ALLO-041 |
|
March 2011 |
June 2013 |
June 2013 |
April 1, 2011 |
July 9, 2014 |
|
- Asan Medical Center
Seoul, Korea, Republic of
|
|
| 18 |
NCT00774449 |
Unknown † |
Characterization of Bronchiolitis-obliterans Syndrome (BOS) Following Lung Transplantation |
- Lung Transplantation
- Bronchiolitis Obliterans Syndrome
|
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Bronchiolitis obliterans Syndrom (BOS)
|
261 |
All |
18 Years to 68 Years (Adult, Older Adult) |
NCT00774449 |
5108 |
|
July 2009 |
June 2014 |
June 2014 |
October 17, 2008 |
July 21, 2011 |
|
- Department of Respiratory Medicine, Medizinische Hochschule Hannover
Hannover, Germany
|
|
| 19 |
NCT01439958 |
Terminated |
Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS) |
|
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS)
- Long-term efficacy outcome over a maximum of three years of patients previously enrolled in phase II/III L-CsA clinical trial 12011.201
|
14 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT01439958 |
12011.203
2011-004304-38 |
|
February 2012 |
July 2013 |
December 2014 |
September 23, 2011 |
April 14, 2015 |
|
- PARI Pharma GmbH
Graefelfing, Germany
|
|
| 20 |
NCT01211509 |
Completed |
Montelukast in Bronchiolitis Obliterans Syndrome |
- Bronchiolitis Obliterans
- Lung Transplantation
- Graft Rejection
|
|
Interventional
|
Phase 4 |
- Universitaire Ziekenhuizen Leuven
- KU Leuven
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- survival/retransplantation rate after diagnosis of BOS
- survival/retransplantation rate at 2 years after diagnosis
- Obstructive and restrictive pulmonary function evolution
- (and 4 more...)
|
30 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01211509 |
MLK002 |
MLK002 |
October 2010 |
March 2015 |
March 2015 |
September 29, 2010 |
March 5, 2015 |
|
- UZ Gasthuisberg
Leuven, Belgium
|
|
| 21 |
NCT01175655 |
Completed |
A Study to Evaluate the Potential of Mesenchymal Stromal Cells to Treat Obliterative Bronchiolitis After Lung Transplantation |
- Bronchiolitis Obliterans
- Lung Transplantation
|
|
Interventional
|
Phase 1 |
- The Prince Charles Hospital
- Cell & Tissue Therapies Western Australia
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To establish the safety of infusions of MSC from related or unrelated HLA identical or HLA mismatched donors in the management of bronchiolitis obliterans syndrome after lung transplantation.
- To document changes in lung function and 6 minute walk distance (6MWD) following infusion of MSC
- To document survival post MSC infusion
|
10 |
All |
Child, Adult, Older Adult |
NCT01175655 |
EC 28105 |
MSC in OB |
February 2010 |
July 2015 |
July 2016 |
August 5, 2010 |
October 11, 2016 |
|
- TPCH
Brisbane, Queensland, Australia - RPH
Perth, Western Australia, Australia
|
|
| 22 |
NCT00378677 |
Unknown † |
Dry Powder Inhalation of Cyclosporine A in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome |
- Lung Transplantation
- Bronchiolitis Obliterans
|
- Drug: Cyclosporine A dry powder inhalation (Drug)
|
Interventional
|
Early Phase 1 |
- University Medical Center Groningen
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Forced Expiratory Volume in 1 second before and after intervention
- Amount of lung deposition of cyclosporine A
- Systemic uptake of Cyclosporine A
- Kidney function (GFR and serum creat)
|
7 |
All |
18 Years and older (Adult, Older Adult) |
NCT00378677 |
CSA-DPI |
|
February 2007 |
|
|
September 21, 2006 |
February 7, 2007 |
|
- University Medical Center Groningen
Groningen, Netherlands
|
|
| 23 |
NCT02495597 |
Completed |
LCI and Bronchial Inflammation in Patients With BO |
|
- Other: no intervention - just observational
|
Observational
|
|
- Johann Wolfgang Goethe University Hospital
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- LCI compared to RV/TLC%-pred.
- change of sputum cell count over time (percentage of neutrophils)
- Comparison of low CrP
- (and 12 more...)
|
37 |
All |
6 Years to 28 Years (Child, Adult) |
NCT02495597 |
EC 124/13 |
FRABO-02 |
April 2013 |
November 2013 |
December 2014 |
July 13, 2015 |
July 23, 2015 |
|
- Children's Hospital, Goethe-University
Frankfurt am Main, Hessen, Germany
|
|
| 24 |
NCT01212406 |
Completed |
Vitamin D in Bronchiolitis Obliterans Syndrome |
- Allograft Rejection
- Lung Transplantation
- Bronchiolitis Obliterans
|
|
Interventional
|
Phase 4 |
- Universitaire Ziekenhuizen Leuven
- KU Leuven
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Prevalence of Bronchiolitis Obliterans syndrome (BOS) (grade 1) at 2 years after transplantation
- Prevalence of BOS (grade 1) at 3 years after transplantation
- Bronchoalveolar lavage
- (and 4 more...)
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT01212406 |
VIT001 |
VIT001 |
October 2010 |
September 2013 |
August 2015 |
September 30, 2010 |
November 11, 2015 |
|
- UZ Gasthuisberg
Leuven, Belgium
|
|
| 25 |
NCT02627833 |
Unknown † |
Lung Function, LCI, Bronchial Inflammation and Epigenetics of Patients With BO |
|
|
Observational
|
|
- Johann Wolfgang Goethe University Hospital
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
|
20 |
All |
6 Years to 35 Years (Child, Adult) |
NCT02627833 |
MRosewich |
FRABO-03 |
October 2015 |
July 2016 |
|
December 11, 2015 |
December 11, 2015 |
|
- Children's Hospital, Goethe-University
Frankfurt am Main, Hessen, Germany
|
|
| 26 |
NCT01807975 |
Completed |
Forced Oscillation Versus Spirometry in Diagnosing Post Pulmonary Transplant Bronchiolitis Obliterans Syndrome |
- Bronchiolitis Obliterans Syndrome
|
- Other: Forced oscillation
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Time difference in diagnosing distal airways functional disturbance by forced oscillation and by spirometry (standard methode).
|
110 |
All |
18 Years and older (Adult, Older Adult) |
NCT01807975 |
2010/56 |
OSCILLOPOUMON |
September 2011 |
September 2015 |
September 2015 |
March 8, 2013 |
July 28, 2016 |
|
- Hôpital FOCH
Suresnes, Ile de France, France
|
|
| 27 |
NCT01112241 |
Completed
Has Results |
Bronchodilator Responsiveness in Obliterative Bronchiolitis |
- Obliterative Bronchiolitis
|
- Drug: albuterol plus tiotropium
|
Interventional
|
Phase 4 |
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Per Cent Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators
- Absolute Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators
- Per Cent Change of Forced Vital Capacity (FVC) After Bronchodilators
- (and 7 more...)
|
17 |
All |
Child, Adult, Older Adult |
NCT01112241 |
BOS-01 |
BD-OB |
April 2010 |
May 2010 |
May 2010 |
April 28, 2010 |
March 2, 2011 |
February 23, 2011 |
- Unit of Preventive and Occupational Medicine - Laboratory of Respiratory Pathophysiology, University Hospital San Martino
Genoa, Italy
|
|
| 28 |
NCT03315741 |
Recruiting |
The Safety and Tolerability of Pirfenidone for BOS After HCT |
- Bronchiolitis Obliterans
- Graft Vs Host Disease
|
- Drug: Pirfenidone 267 MG [Esbriet]
|
Interventional
|
Phase 1 |
- Stanford University
- Genentech, Inc.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The number of participants that do not require a reduction in drug dose for more than 21 days due to adverse events.
- The number of participants that permanently discontinue drug due to adverse events.
- The number of participants that temporarily discontinue drug due to adverse events.
- (and 12 more...)
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT03315741 |
VAR0158
IRB-43319 |
STOP-BOS |
March 1, 2018 |
January 31, 2020 |
March 31, 2020 |
October 20, 2017 |
September 12, 2018 |
|
- Stanford University School of Medicine
Palo Alto, California, United States
|
|
| 29 |
NCT01163786 |
Active, not recruiting |
A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD |
|
|
Interventional
|
Phase 2 |
- Northwestern University
- Robert H. Lurie Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in pulmonary function as measured by FEV1 from baseline and 9 weeks later.
- Exercise Tolerance- 6 minute walk at baseline and 9 weeks later.
- Quality of Life-SF-36 at baseline and 9 weeks later.
|
20 |
All |
Child, Adult, Older Adult |
NCT01163786 |
NU 09H7
STU00022160 |
|
July 2010 |
June 2019 |
June 2020 |
July 16, 2010 |
January 11, 2018 |
|
- Northwestern University
Chicago, Illinois, United States
|
|
| 30 |
NCT02109237 |
Recruiting |
Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3 |
- Bronchiolitis Obliterans
- Sleep Disordered Breathing Central
|
- Procedure: Assessment of sleep disorders and treatment if required
|
Interventional
|
Not Applicable |
- The Prince Charles Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients
- Quality of life assessment using Rand SF36 standard survey
|
75 |
All |
18 Years and older (Adult, Older Adult) |
NCT02109237 |
HREC/13/QPCH/217 |
|
May 2014 |
September 2018 |
September 2019 |
April 9, 2014 |
May 3, 2017 |
|
- The Prince Charles Hospital
Brisbane, Queensland, Australia
|
|
| 31 |
NCT01429844 |
Completed |
Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation |
- Bronchiolitis Obliterans
- Immunosuppression
|
- Drug: Tacrolimus
- Drug: Cyclosporine
|
Interventional
|
Phase 3 |
- Universitätsklinikum Hamburg-Eppendorf
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Incidence of bronchiolitis obliterans syndrome
- Acute allograft rejection
- Patient and graft survival
- (and 3 more...)
|
274 |
All |
18 Years to 66 Years (Adult, Older Adult) |
NCT01429844 |
EAILTx Tac vs. CsA in LuTx |
EAILTX |
January 2001 |
October 2007 |
August 2010 |
September 7, 2011 |
September 7, 2011 |
|
- St. Vincent's Hospital
Sydney, Australia - Allgemeines Krankenhaus Wien
Wien, Austria - Hospital Erasme
Bruxelles, Belgium - (and 11 more...)
|
|
| 32 |
NCT01255449 |
Completed
Has Results |
Respiratory Impedance and Obliterative Bronchiolitis |
- Hematopoietic Stem Cell Transplantation
- Obliterative Bronchiolitis
|
|
Interventional
|
Not Applicable |
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Airway Distensibility With Lung Inflation After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
- Post-HSCT Changes in Lung Tissue Density
|
26 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT01255449 |
FOT-BOS-01 |
FOT-BOS |
December 2010 |
March 2012 |
June 2012 |
December 7, 2010 |
January 31, 2013 |
January 31, 2013 |
- U.O. Medicina Preventiva e del Lavoro, Laboratorio di Fisiopatologia Respiratoria, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro
Genova, Italy
|
|
| 33 |
NCT02669251 |
Recruiting |
AZD9668, an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation |
- Chronic Graft vs Host Disease
- Chronic Graft-Versus-Host-Disease
- Bronchiolitis Obliterans Syndrome
|
|
Interventional
|
Phase 1
Phase 2 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Optimal biologic dose (OBD) based on maximal NE inhibition measured in sputum
- To determine the clinical efficacy of AZD9668 at the OBD in patients with BOS after SCT
- determine the safety of AZD9668
- (and 6 more...)
|
34 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT02669251 |
160060
16-C-0060 |
|
April 28, 2016 |
September 30, 2020 |
September 30, 2020 |
February 1, 2016 |
November 12, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 34 |
NCT00367419 |
Completed |
Use of Erythromycin in Mustard-Induced Bronchiolitis |
- Bronchiolitis Obliterans
- Acute Obliterating Bronchiolitis
|
|
Interventional
|
Phase 4 |
- Baqiyatallah Medical Sciences University
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double
- Primary Purpose: Treatment
|
|
|
Male |
Child, Adult, Older Adult |
NCT00367419 |
S-340-14-6-1-PU-02 |
|
|
|
|
August 22, 2006 |
November 5, 2008 |
|
- Baqiyatallah Medical Sciences University
Tehran, Iran, Islamic Republic of
|
|
| 35 |
NCT02262299 |
Recruiting |
European Trial of Pirfenidone in BOS, A European Multi-center Study |
- Disorder Related to Lung Transplantation
- CLAD, Bronchiolitis Obliterans
|
- Drug: Pirfenidone
- Drug: Placebo
|
Interventional
|
Phase 2
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- To evaluate the effect of Pirfenidone on the change in FEV1 in liters over 6 months in lung transplant recipients with bronchiolitis obliterans syndrome.
- - Categorical percentage change in FEV1
- - Change in Forced Vital Capacity (FVC)
- (and 9 more...)
|
80 |
All |
18 Years and older (Adult, Older Adult) |
NCT02262299 |
RH-HJE-2014-09 |
EPOS |
May 2015 |
December 2018 |
October 2019 |
October 13, 2014 |
August 31, 2018 |
|
- University Hospital Gasthuisberg, Katholike Universiteit Leuven
Leuven, Belgium - Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark - University Hospital Essen, Department of Pneumonology
Essen, Germany - (and 6 more...)
|
|
| 36 |
NCT03283007 |
Not yet recruiting |
Nintedanib in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome Grade 1-2 |
- Lung-transplant Recipients
|
- Drug: Nintedanib
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Nintedanib efficacy in the reduction of the rate of decline of FEV1 (forced expiratory volume in 1 sec) in BOS post-LTx at a dose of 150 mg twice daily (bid) compared to placebo over 6 months
- Nintedanib efficacy on exercise tolerance in LTx recipients
- Nintedanib efficacy on quality of life improvement in LTx recipients
- (and 5 more...)
|
80 |
All |
18 Years and older (Adult, Older Adult) |
NCT03283007 |
AOR16076 - P160907 |
INFINITx-BOS |
October 2018 |
October 2021 |
May 2022 |
September 14, 2017 |
April 26, 2018 |
|
|
|
| 37 |
NCT00656058 |
Completed
Has Results |
Montelukast to Treat Bronchiolitis Obliterans |
- Bronchiolitis Obliterans
- Chronic Graft Versus Host Disease
- Leukotriene
- (and 2 more...)
|
- Drug: Singulair (Montelukast Sodium)
|
Interventional
|
Phase 2 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature
- Number of Participants With Improved, Stable or Declined Forced Expiratory Volume 1 (FEV-1) Slope at 6 Months
- Number of Participants With Adverse Events
- (and 3 more...)
|
25 |
All |
6 Years to 80 Years (Child, Adult, Older Adult) |
NCT00656058 |
080097
08-C-0097 |
|
June 17, 2008 |
May 2, 2014 |
February 22, 2018 |
April 10, 2008 |
April 9, 2018 |
October 21, 2016 |
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 38 |
NCT00861900 |
Completed |
Immune Mechanisms of Rejection in Human Lung Allografts |
|
|
Observational
|
|
- Washington University School of Medicine
- National Institutes of Health (NIH)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The primary efficacy event is the change in pulmonary function testing values (FEV1).
- Secondary efficacy measurements include allograft and patient survival, incidence of BOS and Obliterative bronchiolitis.
|
778 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT00861900 |
98-0977-201103312
HL056643 |
|
January 1998 |
July 2017 |
July 2017 |
March 16, 2009 |
June 19, 2018 |
|
|
|
| 39 |
NCT02316392 |
Completed |
Imaging and Understanding BOS in Lung Transplantation |
- Bronchiolitis Obliterans Syndrome
|
- Drug: Hyperpolarized Helium-3 MRI
|
Observational
|
|
- Children's Hospital Medical Center, Cincinnati
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Analysis of MRI imaging to detect BOS compared to biopsy
|
6 |
All |
1 Year to 25 Years (Child, Adult) |
NCT02316392 |
2014-6004 |
|
December 2014 |
February 2017 |
February 2017 |
December 12, 2014 |
March 10, 2017 |
|
- Children's Hospital Medical Center
Cincinnati, Ohio, United States
|
|
| 40 |
NCT01273207 |
Recruiting |
Extension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans |
- Bronchiolitis Obliterans
- Constructive Bronchiolitis
- Graft Versus Host Disease
- (and 2 more...)
|
- Drug: Cyclosporine Inhalation Solution (CIS)
|
Interventional
|
Phase 2 |
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Toxicity profile (adverse events) and efficacy of extended use CIS for BO/BOS
|
78 |
All |
10 Years to 80 Years (Child, Adult, Older Adult) |
NCT01273207 |
110064
11-H-0064 |
|
March 2, 2012 |
June 30, 2025 |
June 30, 2025 |
January 10, 2011 |
February 11, 2019 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 41 |
NCT01633385 |
Completed |
Bronchial Inflammation in Patients With Bronchiolithis Obliterans |
|
|
Observational
|
|
- Johann Wolfgang Goethe University Hospital
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Change of FEF75 over time
- change of sputum cell count over time
- change of low CrP over time
|
37 |
All |
6 Years to 25 Years (Child, Adult) |
NCT01633385 |
BO2012-02 |
FRABO-02 |
April 2012 |
June 2012 |
December 2012 |
July 4, 2012 |
April 4, 2013 |
|
- Children's Hospital, Goethe-University
Frankfurt am Main, Hessen, Germany
|
|
| 42 |
NCT01287078 |
Completed |
Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans |
- Constrictive Bronchiolitis
- Bronchiolitis Obliterans
- Graft vs Host Disease
- (and 2 more...)
|
- Drug: Cyclosporine Inhalation Solution
|
Interventional
|
Phase 2 |
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- FEV1 improvement or stabilization from study baseline by week 9 or thereafter, for at least two successive measure (efficacy) and the toxicity profile as measured by CTCAE criteria (safety).
|
25 |
All |
10 Years to 80 Years (Child, Adult, Older Adult) |
NCT01287078 |
110068
11-H-0068 |
|
January 29, 2011 |
August 8, 2018 |
August 8, 2018 |
February 1, 2011 |
January 18, 2019 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 43 |
NCT03674047 |
Recruiting |
Ruxolitinib for Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplantation (HCT) |
|
|
Interventional
|
Phase 2 |
- Massachusetts General Hospital
- Incyte Corporation
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- absolute FEV1 increase
- treatment failure, comparing 3-month FEV1 to baseline FEV1
- Change scores for PFT measurements
- (and 5 more...)
|
50 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03674047 |
18-265 |
|
February 28, 2019 |
March 31, 2022 |
March 31, 2023 |
September 17, 2018 |
January 1, 2019 |
|
- Dana Farber Cancer Institute
Boston, Massachusetts, United States
|
|
| 44 |
NCT01959100 |
Active, not recruiting |
Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation |
- Malignant Hematological Diseases
|
- Drug: Azithromycin
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Airflow decline (AFD)-free survival
- Overall survival
- Occurrence of late-onset pulmonary non-infectious complications (=bronchiolitis obliterans syndrome, SBO)
- (and 6 more...)
|
480 |
All |
16 Years and older (Child, Adult, Older Adult) |
NCT01959100 |
P120110 |
ALLOZITHRO |
February 2014 |
April 2017 |
August 2020 |
October 9, 2013 |
July 23, 2018 |
|
- Saint Louis
Paris, Ile De France, France
|
|
| 45 |
NCT02181712 |
Completed |
Mesenchymal Stem Cell Therapy for Lung Rejection |
- Lung Transplant Reject
- Bronchiolitis Obliterans
|
- Biological: Mesenchymal stem cell
|
Interventional
|
Phase 1 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants with serious and non-serious adverse events
- Changes in pulmonary function tests
|
9 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02181712 |
14-000025 |
|
July 2014 |
September 2016 |
December 2016 |
July 4, 2014 |
August 11, 2017 |
|
- Mayo Clinic in Florida
Jacksonville, Florida, United States
|
|
| 46 |
NCT00755781 |
Completed |
Study of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation |
|
- Drug: Cyclosporine Inhalation Solution (CIS)
|
Interventional
|
Phase 3 |
- APT Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Duration of BOS-free survival. Other causes for the decline should be excluded by bronchoscopy and other diagnostic testing performed at the discretion of the investigator. The diagnosis of BOS will be determined by the Outcomes Committee
- Pulmonary function as measured by mean FEV1 percent predicted at 2 years after randomization
- All cause mortality
- Duration of event-free survival, corresponding to the length of time between date of randomization and either death or the occurrence of serious bacterial and viral infections that start in the lungs (defined by reporting of a SAE)
|
284 |
All |
18 Years and older (Adult, Older Adult) |
NCT00755781 |
CIS001 |
CIS001 |
September 2008 |
September 2011 |
November 2011 |
September 19, 2008 |
September 17, 2012 |
|
- UCLA School of Medicine
Los Angeles, California, United States - University of California, San Francisco
San Francisco, California, United States - Stanford University Medical Center
Stanford, California, United States - (and 16 more...)
|
|
| 47 |
NCT01469364 |
Completed
Has Results |
Safety Study of Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS) |
- Complication of Transplanted Lung
|
- Drug: Aztreonam Lysine for Inhalation (AZLI)
- Procedure: Status Post Lung Transplant
|
Interventional
|
Phase 4 |
- Duke University
- Gilead Sciences
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry
- Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1
- Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1 and Month 5.
- (and 8 more...)
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT01469364 |
Pro00030559
Gilead Sciences, Inc
Pro00030191 |
AZLI |
March 2013 |
March 2015 |
April 2015 |
November 10, 2011 |
January 29, 2016 |
November 26, 2015 |
- David Geffen School of Medicine at UCLA
Los Angeles, California, United States - Duke University Medical Center
Durham, North Carolina, United States
|
|
| 48 |
NCT02488304 |
Terminated |
Prospective Study for Transplant Optimization Using Functional Imaging (TROFI) |
- Bronchiolitis Obliterans
- Lung Transplant Rejection
|
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Change in Airway Volume (iVaw) using FRI
- Change in Airway Resistance (iRaw) using FRI
- Change in Specific Airway Volume (siVaw) using FRI
- (and 7 more...)
|
10 |
All |
18 Years and older (Adult, Older Adult) |
NCT02488304 |
FLUI-2015-141 |
|
July 2015 |
December 15, 2017 |
December 15, 2017 |
July 2, 2015 |
March 21, 2018 |
|
- Antwerp University Hospital
Edegem, Antwerp, Belgium
|
|
| 49 |
NCT02364674 |
Completed |
Transplant Optimization Using Functional Imaging |
- Bronchiolitis Obliterans
- Lung Transplant Rejection
|
- Radiation: High Resolution Computed Tomography scan
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Airway Volume (iVaw)
- Airway Resistance (iRaw)
- Specific Airway Volume (siVaw)
- (and 7 more...)
|
8 |
All |
18 Years and older (Adult, Older Adult) |
NCT02364674 |
FLUI-2014-103_USA |
TROFI |
February 2015 |
January 9, 2017 |
January 9, 2017 |
February 18, 2015 |
March 29, 2017 |
|
- Columbia University Medical Center
New York, New York, United States - Hospital of the University of Pennsylvania
Gibson, Pennsylvania, United States
|
|
| 50 |
NCT02441413 |
Completed |
Transplant Optimization Using Functional Imaging (TROFI) |
- Bronchiolitis Obliterans
- Lung Transplant Rejection
|
- Radiation: High Resolution Computed Tomography scans
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Airway Volume (iVaw) using FRI
- Airway Resistance (iRaw) using FRI
- Specific Airway Volume (siVaw) using FRI
- (and 7 more...)
|
3 |
All |
18 Years and older (Adult, Older Adult) |
NCT02441413 |
FLUI-2014-103_BE |
TROFI_BE |
September 2015 |
November 8, 2016 |
November 8, 2016 |
May 12, 2015 |
March 29, 2017 |
|
- Antwerp University Hospital
Edegem, Antwerp, Belgium
|
|
| 51 |
NCT01650545 |
Completed
Has Results |
Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients |
- Disorder Related to Lung Transplantation
- Bronchiolitis Obliterans
- Decreased Immunologic Activity
- Chronic Rejection of Lung Transplant
|
- Drug: Liposomal aerosol cyclosporine
- Other: standard immune suppression, oral
|
Interventional
|
Phase 1
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number Of Participants With Chronic Rejection Who Met Primary Combined End-point
- Cytokine Analysis From BAL Fluid in Lung
- Overall Survival at 5 Years Follow-up
|
21 |
All |
18 Years and older (Adult, Older Adult) |
NCT01650545 |
HP-00049596 |
|
July 2012 |
August 2015 |
August 2015 |
July 26, 2012 |
March 2, 2018 |
October 25, 2017 |
- University of Maryland Medical Center
Baltimore, Maryland, United States
|
|
| 52 |
NCT00624754 |
Completed |
Prospective Evaluation of the Efficacy of Budesonide/Formoterol in Bronchiolitis Obliterans in AHSCT |
- Obstructive Airway Disease
|
- Drug: Formoterol/Budesonide
- Drug: lactose
|
Interventional
|
Phase 2 |
- Assistance Publique - Hôpitaux de Paris
- AstraZeneca
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The primary endpoint is based on pulmonary function tests (PFT): the absolute variation of FEV1 after 1 month of treatment will be assessed.
- Improvement or stabilisation of FEV1; Prevalence of improvement of FEV1 by at least 200 ml and 12% at 1 month compared to baseline; Variation of FEF 25-75% and vital capacity; Quality of life measurement; Evaluation of the clinical score
|
32 |
All |
16 Years and older (Child, Adult, Older Adult) |
NCT00624754 |
P070116 |
Alloforb |
March 2008 |
July 2012 |
July 2012 |
February 27, 2008 |
May 6, 2013 |
|
- Hôpital Saint Louis
Paris, France
|
|
| 53 |
NCT00381147 |
Completed |
Use of Clarithromycin in Mustard-Induced Bronchiolitis |
- Bronchiolitis Obliterans
- Acute Obliterating Bronchiolitis
|
|
Interventional
|
Phase 3 |
- Baqiyatallah Medical Sciences University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
|
|
Male |
Child, Adult, Older Adult |
NCT00381147 |
S-340-14-6-1-PU-11 |
|
|
|
|
September 27, 2006 |
January 7, 2009 |
|
- Baqiyatallah Medical Sciences University
Tehran, Iran, Islamic Republic of
|
|
| 54 |
NCT00177918 |
Recruiting |
Prospective Evaluations of Infectious Complication in Lung Transplant Recipients |
- Disorder Related to Lung Transplantation
- Bronchiolitis Obliterans
|
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- long term outcome after lung transplantation
|
600 |
All |
18 Years and older (Adult, Older Adult) |
NCT00177918 |
IRB # 0212095 |
|
August 2006 |
December 2025 |
December 2025 |
September 15, 2005 |
June 12, 2018 |
|
- University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
|
|
| 55 |
NCT01009619 |
Completed
Has Results |
Azithromycin in Bronchiolitis Obliterans Syndrome |
- Bronchiolitis Obliterans Syndrome
- Graft Rejection
- Lymphocytic Bronchiolitis
- Respiratory Infection
|
- Drug: Azithromycin
- Drug: Placebo
|
Interventional
|
Phase 4 |
- KU Leuven
- University Hospital, Gasthuisberg
- Fund for Scientific Research, Flanders, Belgium
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Prevalence of Bronchiolitis Obliterans Syndrome (BOS)
- Overall Survival
- Acute Rejection Incidence Rate
- (and 4 more...)
|
83 |
All |
18 Years and older (Adult, Older Adult) |
NCT01009619 |
AZI001
EudraCT ref. 2005-003893-46 |
AZI001 |
September 2005 |
December 2009 |
December 2009 |
November 9, 2009 |
October 3, 2011 |
August 25, 2011 |
- Katholieke Universiteit Leuven and University Hospital Gasthuisberg
Leuven, Belgium
|
|
| 56 |
NCT00188825 |
Completed |
Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung Transplant |
- COPD
- Emphysema
- Alpha-1 Antitrypsan Deficiency
|
- Other: placebo
- Drug: basiliximab
|
Interventional
|
Phase 3 |
- University Health Network, Toronto
- Novartis
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The proportion of patients who experience one or more acute allograft rejections in the first six months of treatment.
- The proportion of patients who experience one or more acute allograft rejections by 1 year post-transplantation.
|
22 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00188825 |
CCHI621AES05 |
|
May 2004 |
October 2007 |
October 2007 |
September 16, 2005 |
May 4, 2017 |
|
- Toronto General Hospital
Toronto, Ontario, Canada
|
|
| 57 |
NCT00891865 |
Completed |
Viral Triggers in Pediatric Lung Transplantation |
- Lung Transplant
- Bronchiolitis Obliterans
- Obliterative Bronchiolitis
|
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Heart, Lung, and Blood Institute (NHLBI)
|
NIH |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- The earliest time to BOS or OB, retransplantation or death
- Time to each of the following events: BOS or OB, retransplantation or death
|
61 |
All |
up to 21 Years (Child, Adult) |
NCT00891865 |
DAIT CTOTC-03 |
|
June 2009 |
April 2015 |
April 2015 |
May 1, 2009 |
May 27, 2015 |
|
- Stanford University
Palo Alto, California, United States - Children's Hospital Boston
Boston, Massachusetts, United States - Washington University
St.Louis, Missouri, United States - (and 3 more...)
|
|
| 58 |
NCT00163696 |
Unknown † |
Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease |
- Cystic Fibrosis
- Asthma
- Bronchiolitis Obliterans
- Lung Transplantation
|
|
Observational
|
|
|
Other |
- Observational Model: Defined Population
- Observational Model: Natural History
- Time Perspective: Cross-Sectional
- Time Perspective: Prospective
|
|
90 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00163696 |
MBNW alfred |
|
September 2004 |
|
|
September 14, 2005 |
July 26, 2007 |
|
- Alfred Hospital
Melbourne, Victoria, Australia
|
|
| 59 |
NCT00027235 |
Completed |
Popcorn Lung: the Discovery of a New Disease |
- Lung Diseases, Interstitial
- Bronchiolitis Obliterans
|
|
Observational
|
|
- National Center for Research Resources (NCRR)
|
NIH |
- Observational Model: Defined Population
- Observational Model: Natural History
- Time Perspective: Longitudinal
|
|
|
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00027235 |
NCRR-M01RR00036-0829 |
|
|
|
|
November 29, 2001 |
June 24, 2005 |
|
- Washington University, Division of Pulmonary and Critical Care Medicine
St. Louis, Missouri, United States
|
|
| 60 |
NCT02863835 |
Completed |
Evaluation of Electrical Impedance Tomography for the Diagnosis of Chronic Rejection in Lung Transplants Recipients |
- Transplantation, Heart-Lung
- Chronic Lung Allograft Dysfunction
- Bronchiolitis Obliterans Syndrome
|
- Other: EIT
- Other: Salbutamol nebulisation and with CPAP
|
Interventional
|
Not Applicable |
- Guy's and St Thomas' NHS Foundation Trust
- ADIR Association
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number of chronic lung allograft dysfunction in lung transplant recipients identified with EIT
- Restrictive and obstructive phenotypes in recipients of lung transplants.
- Change in EIT results following administration of salbutamol and CPAP
- (and 4 more...)
|
50 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02863835 |
16/LO/0198 |
CLAD |
April 2016 |
June 2017 |
June 2017 |
August 11, 2016 |
May 28, 2018 |
|
- Guys and St Thomas NHS Foundation
London, United Kingdom
|
|
| 61 |
NCT00449332 |
Terminated |
Early Indicators of Chronic Rejection in Lung Transplant |
- Chronic Rejection in Lung Transplant
- Cytokine Production in Bos Post Lung Transplant
|
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- cytokines, chemokines and T cell subsets associated with BOS
|
120 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00449332 |
14516A |
BOS |
March 2006 |
December 2013 |
December 2013 |
March 20, 2007 |
September 20, 2016 |
|
- The University of Chicago
Chicago, Illinois, United States
|
|
| 62 |
NCT01206309 |
Completed |
Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation |
- Graft vs Host Disease
- Cutaneous Sclerosis
- Bronchiolitis Obliterans
|
|
Observational
|
|
- Fred Hutchinson Cancer Research Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The prevalence of immune mediated disorders
- Banked blood and urine samples
|
911 |
All |
Child, Adult, Older Adult |
NCT01206309 |
RDCRN 6501
U54CA163438
RDCRN-6501
2342.00 |
|
March 2011 |
October 2016 |
October 2016 |
September 21, 2010 |
October 7, 2016 |
|
- Mayo Clinic
Scottsdale, Arizona, United States - Stanford University
Stanford, California, United States - H. Lee Moffitt Cancer Center
Tampa, Florida, United States - (and 11 more...)
|
|
| 63 |
NCT00743171 |
Completed |
Long-Term Study On Home Spirometry After Lung Transplantation |
- Lung Transplantation
- Rejection
- Death
- Bronchiolitis Obliterans
|
|
Observational
|
|
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Graft loss
- BOS
- Number of acute rejections
- Number of hospitalizations
|
152 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT00743171 |
MHH 2008-3 |
|
January 2000 |
December 2007 |
December 2007 |
August 28, 2008 |
August 29, 2008 |
|
- Hannover Medical School
Hannover, Germany
|
|
| 64 |
NCT02543073 |
Unknown † |
MSC for Treatment of Interstitial Lung Disease After Allo-HSCT |
- Lung Diseases, Interstitial
- Hematopoietic Stem Cell Transplantation
- Bronchiolitis Obliterans
|
- Biological: MSCs
- Drug: AZM
- Drug: Glucocorticoid
|
Interventional
|
Phase 1
Phase 2 |
- Nanfang Hospital of Southern Medical University
- Sun Yat-sen University
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response rate of ILD
- Overall Survival
|
60 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02543073 |
MSC-ILD-2015 |
|
September 2014 |
December 2017 |
June 2018 |
September 7, 2015 |
May 10, 2017 |
|
- Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
|
|
| 65 |
NCT00141726 |
Completed
Has Results |
Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant |
- Lung Injury, Acute
- Respiratory Distress Syndrome, Adult
- Bronchiolitis Obliterans
|
|
Interventional
|
Phase 2 |
- University of Michigan Rogel Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO
- Percentage of Participants That Experience Grade 3 to 4 Adverse Events
|
34 |
All |
6 Years and older (Child, Adult, Older Adult) |
NCT00141726 |
UMCC 3-31
IRBMED 2003-0590 and HUM 46747 |
|
October 2003 |
July 2008 |
February 2009 |
September 1, 2005 |
December 3, 2015 |
June 19, 2014 |
- The University of Michigan Cancer Center
Ann Arbor, Michigan, United States
|
|
| 66 |
NCT00029328 |
Completed |
Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation |
- Respiratory Distress Syndrome, Adult
- Bronchiolitis Obliterans
- Pneumonia
|
|
Interventional
|
Phase 1
Phase 2 |
- FDA Office of Orphan Products Development
|
U.S. Fed |
- Allocation: Non-Randomized
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
15 |
All |
12 Months and older (Child, Adult, Older Adult) |
NCT00029328 |
FD-R-2020-01
UMCC-0078;
FD-R-002020-01 |
|
September 2001 |
|
September 2003 |
January 11, 2002 |
March 25, 2015 |
|
- University of Michigan
Ann Arbor, Michigan, United States
|
|
| 67 |
NCT02657837 |
Unknown † |
Measures of Respiratory Health (MRH) |
- Cystic Fibrosis
- Asthma
- Sickle Cell Anemia
- Bronchiolitis Obliterans
|
|
Observational
|
|
- The Hospital for Sick Children
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Proportion of patients with an abnormal Lung Clearance Index (>7.5).
- . Proportion of patients with an abnormal pulmonary function tests based on spirometry.
|
300 |
All |
30 Months to 30 Years (Child, Adult) |
NCT02657837 |
1000051399 |
MRH |
January 2016 |
December 2018 |
December 2018 |
January 18, 2016 |
October 14, 2016 |
|
- The Hospital for Sick Children
Toronto, Ontario, Canada
|
|
| 68 |
NCT00701922 |
Completed |
Surveillance Study of Viral Infections Following Lung Transplantation |
- Lung Transplantation
- Bronchiolitis Obliterans
- Epstein-Barr Virus Infections
- Paramyxoviridae Infections
|
|
Observational
|
|
- Hannover Medical School
- Department of Pulmonology
- Department of Virology
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Incidence of bronchiolitis obliterans syndrome
- Incidence of acute rejection
- Incidence of hospitalisation
- Incidence of graft loss (death or re-do-transplantation)
|
388 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT00701922 |
4015 |
|
October 2005 |
December 2007 |
December 2007 |
June 19, 2008 |
October 28, 2011 |
|
- Hannover Medical School
Hannover, Germany
|
|
| 69 |
NCT01432080 |
Terminated |
Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant |
- Respiratory Tract Infections
- Bronchiolitis Obliterans
- Cryptogenic Organizing Pneumonia
- Lung Diseases, Interstitial
|
- Drug: Prednisone
- Drug: Azithromycin
- Drug: Montelukast
- Drug: Symbicort
|
Interventional
|
Phase 2 |
- Maisonneuve-Rosemont Hospital
- The Canadian Blood and Marrow Transplant Group
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Cumulative incidence of new chronic lung disease
- Prevalence of non-infectious pulmonary complications
- Long-term functional impairment as defined by need for supplemental oxygen
- (and 10 more...)
|
12 |
All |
18 Years and older (Adult, Older Adult) |
NCT01432080 |
HMR1102 |
|
September 2011 |
December 2012 |
December 30, 2013 |
September 12, 2011 |
August 30, 2017 |
|
- Maisonneuve-Rosemont Hospital (Hôpital Maisonneuve-Rosemont)
Montreal, Quebec, Canada
|
|
| 70 |
NCT02032381 |
Active, not recruiting |
Prospective Study of Belated Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells. |
- Bone Marrow Transplant Infection
- Bronchiolitis Obliterans
- Chronic Respiratory Insufficiency
- (and 2 more...)
|
- Other: late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.
|
Interventional
|
Not Applicable |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- Presence of belated non-infectious pulmonary complications
- Presence of risk factors for belated non-infectious pulmonary complications
- Survival three years
- Severity of respiratory disease
|
300 |
All |
up to 18 Years (Child, Adult) |
NCT02032381 |
P120137
2013-A00966-39 |
RESPPEDHEM |
January 2014 |
January 2019 |
January 2019 |
January 10, 2014 |
June 20, 2018 |
|
- Houdouin véronique
Paris, France
|
|
| 71 |
NCT00956358 |
Completed |
Study on Systemic and Airway Biomarkers in Haemopoietic Stem Cell Transplantation |
|
|
Observational
|
|
- The University of Hong Kong
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
|
228 |
All |
18 Years and older (Adult, Older Adult) |
NCT00956358 |
UW 09-107 |
|
March 2009 |
December 2015 |
December 2015 |
August 11, 2009 |
May 12, 2016 |
|
- Queen Mary Hospital
Hong Kong, Hong Kong
|
|
| 72 |
NCT03237364 |
Recruiting |
Iraq- Afghanistan War Lung Injury Using 19F MRI (DIAL1001006) |
- Constrictive Bronchiolitis
- Iraq-Afganistan War Lung Injury Syndrome
|
- Diagnostic Test: Perfluorinated Gas/Oxygen Mixture
|
Interventional
|
Early Phase 1 |
- Hal C Charles
- Duke University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Lung Ventilatory Heterogeneity defined by parametric imaging with 19F perfluorinated gas/oxygen mixtures
|
10 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT03237364 |
Pro00076112 |
|
August 19, 2017 |
March 30, 2019 |
April 15, 2019 |
August 2, 2017 |
November 7, 2018 |
|
- Duke Image Analysis Laboratory
Durham, North Carolina, United States
|
|
| 73 |
NCT00980967 |
Unknown † |
Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study |
- Chronic Rejection
- Lung Transplantation
|
- Other: Study of predictive factors
|
Interventional
|
Not Applicable |
- Nantes University Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- Identification of predictive factors for lung chronic rejection outcome in lung transplant recipients. This primary outcome will be evaluated at the end of the study.
- Evaluate the pertinence of a monitoring of lung chronic rejection based on the predictive factors identified in the study, in order to prevent this rejection. The secondary outcome measure will be evaluated at the end of the study.
|
700 |
All |
18 Years and older (Adult, Older Adult) |
NCT00980967 |
BRD 09/1-F |
COLT |
September 2009 |
September 2017 |
September 2017 |
September 21, 2009 |
May 12, 2015 |
|
- CHU de Bordeaux
Bordeaux, France - CHU de Grenoble
Grenoble, France - Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, France - (and 8 more...)
|
|
| 74 |
NCT02631720 |
Active, not recruiting |
CLAD Phenotype Specific Risk Factors and Mechanisms |
- Lung Transplant
- Post Lung Transplantation
|
- Procedure: Blood Draw
- Procedure: Bronchoscopy
|
Observational
|
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- Clinical Trials in Organ Transplantation
|
NIH / Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Time from transplant to Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS).
- Longitudinal Quality of life (QOL) trajectory
- Time from transplant to death or retransplant
- (and 3 more...)
|
884 |
All |
18 Years and older (Adult, Older Adult) |
NCT02631720 |
DAIT CTOT-20 |
|
December 22, 2015 |
December 2020 |
December 2020 |
December 16, 2015 |
November 30, 2018 |
|
- University of California, Los Angeles
Los Angeles, California, United States - Johns Hopkins University
Baltimore, Maryland, United States - Duke University
Durham, North Carolina, United States - (and 2 more...)
|
|
| 75 |
NCT00938236 |
Terminated |
CIS001 Extension Study of Cyclosporine Inhalation Solution |
|
- Drug: Cyclosporine Inhalation Solution (CIS)
|
Interventional
|
Phase 3 |
- APT Pharmaceuticals, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- To assess the long-term safety of CIS administration
|
17 |
All |
18 Years and older (Adult, Older Adult) |
NCT00938236 |
CIS002 |
CIS002 |
December 2009 |
September 2011 |
December 2011 |
July 13, 2009 |
September 17, 2012 |
|
- UCLA School of Medicine
Los Angeles, California, United States - University of California, San Francisco
San Francisco, California, United States - Stanford University Medical Center
Stanford, California, United States - (and 13 more...)
|
|
| 76 |
NCT02036970 |
Completed |
Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT |
- Pulmonary Arterial Hypertension
- Pulmonary Hypertension
- Interstitial Lung Disease
- (and 9 more...)
|
- Drug: Bardoxolone methyl
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Reata Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change from baseline in 6-Minute Walk Distance (6MWD)
|
166 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02036970 |
RTA 402-C-1302 |
|
May 2014 |
January 19, 2018 |
May 16, 2018 |
January 15, 2014 |
January 3, 2019 |
|
- Banner University Medical Center, Phoenix Advanced Lung Disease Institute
Phoenix, Arizona, United States - Arizona Pulmonary Specialists
Phoenix, Arizona, United States - Cedars Sinai Medical Center
Beverly Hills, California, United States - (and 29 more...)
|
|
| 77 |
NCT02936505 |
Recruiting |
Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD. |
- Lung Transplantation
- Allografts
|
- Drug: Cyclosporine
- Drug: Mycophenolate mofetil (MMF)
- Drug: Rabbit Anti thymocyte globulin
- (and 2 more...)
|
Interventional
|
Not Applicable |
- Vastra Gotaland Region
- Oslo University Hospital
- Helsinki University Central Hospital
- (and 2 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients with incidence of CLAD
- Glomerular Filtration Rate
- Primary graft dysfunction
- (and 21 more...)
|
242 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02936505 |
Version 6.0
154-16
2015-004137-27 |
ScanCLAD |
October 2016 |
June 2022 |
February 2023 |
October 18, 2016 |
October 23, 2018 |
|
- Rigshospitalet
Copenhagen, Denmark - Helsinki University Hospital
Helsinki, Finland - Oslo University Hospital
Oslo, Norway - (and 2 more...)
|
|
| 78 |
NCT00633373 |
No longer available |
Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients |
|
- Drug: Cyclosporine Inhalation Solution
|
Expanded Access
|
|
- APT Pharmaceuticals, Inc.
|
Industry |
|
|
|
All |
Child, Adult, Older Adult |
NCT00633373 |
ACS004 |
|
|
|
|
March 12, 2008 |
September 17, 2012 |
|
- University of California at San Francisco
San Francisco, California, United States - University of Florida Health Sciences Center
Gainesville, Florida, United States - Tampa General Hospital
Tampa, Florida, United States - (and 5 more...)
|
|
| 79 |
NCT00340951 |
Completed |
Can Immune Parameters Predict Acute and Chronic Rejection in Lung Recipients? |
|
|
Observational
|
|
- National Institute of Environmental Health Sciences (NIEHS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
400 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT00340951 |
999905183
05-E-N183 |
|
June 23, 2005 |
|
April 13, 2007 |
June 21, 2006 |
July 2, 2017 |
|
- Duke University Medical Center
Durham, North Carolina, United States - NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, United States
|
|
| 80 |
NCT00339209 |
Completed |
Prospective Lung Transplant Database for Genetic Research |
- Lung Transplantation Rejection
|
|
Observational
|
|
- National Institute of Environmental Health Sciences (NIEHS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
400 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT00339209 |
999905184
05-E-N184 |
|
June 23, 2005 |
|
April 13, 2007 |
June 21, 2006 |
July 2, 2017 |
|
- Duke University Medical Center
Durham, North Carolina, United States - NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, United States
|
|
| 81 |
NCT01109160 |
Completed |
Study of Azithromycin for Lymphocytic Bronchiolitis/Bronchitis After Lung Transplantation |
- Lymphocytic Bronchi(Oli)Tis Post-lung Transplantation
|
- Drug: Azithromycin Dihydrate
|
Interventional
|
Phase 4 |
- KU Leuven
- Fund for Scientific Research, Flanders, Belgium
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Histology on bronchial and/or transbronchial biopsies
- Pulmonary function (FEV1)
- Bronchoalveolar cellularity and protein levels (IL-8, IL-17)
- Radiologic features
|
15 |
All |
18 Years and older (Adult, Older Adult) |
NCT01109160 |
AZI002
2010-018724-16 |
AZI002 |
April 2010 |
October 2012 |
July 2013 |
April 23, 2010 |
July 4, 2013 |
|
- University Hospital Gasthuisberg
Leuven, Vlaams-Brabant, Belgium
|
|
| 82 |
NCT01463475 |
Completed |
University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol |
- Graft Versus Host Disease (GVHD)
- Acute Myocardial Infarction (AMI)
|
- Procedure: Bone marrow aspirate
|
Interventional
|
Not Applicable |
- University of Wisconsin, Madison
- National Heart, Lung, and Blood Institute (NHLBI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- Culture and expand mesenchymal stromal cells (MSC)
- Characterization profile of MSC during and after expansion will be assessed
|
3 |
All |
18 Years to 35 Years (Adult) |
NCT01463475 |
H-2010-0104
HHSN268201000010C |
|
September 2011 |
December 2013 |
December 2013 |
November 2, 2011 |
December 4, 2014 |
|
- University of Wisconsin-Madison
Madison, Wisconsin, United States
|
|
| 83 |
NCT02893176 |
Not yet recruiting |
Macitentan in the Treatment of Organ Rejection After Lung Transplantation |
- Lung Transplant Rejection
|
- Drug: macitentan
- Drug: placebo (for macitentan)
|
Interventional
|
Phase 4 |
- University of California, Los Angeles
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Measure of FEV1
- Measure of Six Minute Walk
- Measure of Pulse Oximetry
- Measure of Diffusing Capacity
|
20 |
All |
21 Years to 65 Years (Adult, Older Adult) |
NCT02893176 |
14-001710 |
|
September 2016 |
February 2020 |
|
September 8, 2016 |
September 8, 2016 |
|
- University of Califonia, Los Angeles
Los Angeles, California, United States
|
|
| 84 |
NCT00402532 |
Completed |
Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation |
|
- Drug: Everolimus
- Drug: Mycophenolatmofetil
|
Interventional
|
Phase 3 |
- Hannover Medical School
- Novartis Pharmaceuticals
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from transplantation
- Incidence and severity of Nephrotoxicity within 2 years of transplantation
- Incidence and severity of opportunistic infections within 2 years of transplantation
|
190 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00402532 |
Ever-Lung-DE01/RAD-LungDE01 |
|
March 2005 |
November 2011 |
December 2011 |
November 22, 2006 |
December 8, 2011 |
|
- Hannover Medical School, Division of Thoracic and Cardiovascular Surgery
Hannover, Germany
|
|
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