Lung Transplantation Clinical Trial
Official title:
Characterization of Bronchiolitis-obliterans Syndrome (BOS) Following Lung Transplantation
Chronic organ dysfunction after lung transplantation (BOS) is the most common cause of death
in long-term survivors after lung transplantation and refractory to most interventions.
Early markers will be established in this project study to overcome the problem of disease
recognition when impairment of graft function is already taken place. Long-term longitudinal
monitoring in stable recipients of innovative markers of airway inflammation and ventilation
and new imaging techniques will define different entities of chronic organ dysfunction after
LTx. A database and specimen service unit for further projects will be created.
Hypothesis: This project will reveal new markers and imaging tools in recipients who develop
BOS after lung transplantation. These tools will allow earlier diagnosis and more accurate
monitoring of the disease process. Different patterns of the disease will be characterized.
Status | Recruiting |
Enrollment | 261 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 68 Years |
Eligibility |
Inclusion Criteria: - Individuals, who have undergone double (DLTx) or heart and lung transplantation (HLTx) at Hannover Medical School 6 months prior to inclusion - Ages: 18 to 68 Years - Gender: both - Stable graft function (FEV1 >90% baseline) Exclusion Criteria: - Severe airway complications after surgery necessitating repeated intervention during the last 3 months - Need for supplemental oxygen at time of inclusion - Single lung (SLTx) and living lobar recipients - Established diagnosis of BOS at time of inclusion - Inability to undergo bodyphlethysmography e.g. due to persistent infection with multi-drug resistant bacteria (MRSA, VRE, Burkholderia Cepacia, Pandorea) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Department of Respiratory Medicine, Medizinische Hochschule Hannover | Hannover |
Lead Sponsor | Collaborator |
---|---|
Hannover Medical School |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bronchiolitis obliterans Syndrom (BOS) | 5 years | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02581111 -
Naloxone for Optimizing Hypoxemia Of Lung Donors
|
Phase 2/Phase 3 | |
Recruiting |
NCT02177916 -
Patient Education Study to Determine Knowledge Acquisition in Patients Preparing to Undergo Lung Transplantation
|
N/A | |
Not yet recruiting |
NCT01394835 -
Safety and Efficacy of Inhaled Alpha-1 Antitrypsin in Preventing Bronchiolitis Obliterable Syndrome in Lung Transplant Recipients
|
Phase 2 | |
Not yet recruiting |
NCT01162148 -
Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation
|
N/A | |
Completed |
NCT01204970 -
Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients
|
N/A | |
Active, not recruiting |
NCT00980967 -
Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study
|
N/A | |
Completed |
NCT00531921 -
Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival
|
N/A | |
Recruiting |
NCT00163696 -
Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease
|
N/A | |
Completed |
NCT00177684 -
Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)
|
Phase 3 | |
Completed |
NCT00163891 -
Comparison of Two Chest Physiotherapy Protocols in Lung Transplant Recipients
|
N/A | |
Completed |
NCT03668483 -
Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx
|
N/A | |
Not yet recruiting |
NCT02855372 -
Impact of the Age Difference Between the Donor and Recipient on the Morbidity and Mortality After Lung Transplantation. Study on a National Multicenter Cohort (COLT)
|
N/A | |
Completed |
NCT01211509 -
Montelukast in Bronchiolitis Obliterans Syndrome
|
Phase 4 | |
Completed |
NCT01212406 -
Vitamin D in Bronchiolitis Obliterans Syndrome
|
Phase 4 | |
Not yet recruiting |
NCT00808600 -
Empowerment of Lung and Heart-lung Transplant Patients
|
N/A | |
Completed |
NCT00553397 -
Live Lung Donor Retrospective Study
|
N/A | |
Completed |
NCT00402805 -
Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy
|
Phase 4 | |
Completed |
NCT00701922 -
Surveillance Study of Viral Infections Following Lung Transplantation
|
N/A | |
Terminated |
NCT00235651 -
Abelcet Radiotagging Protocol: Inhaled Lipid Complex Abelcet® in Lung Transplant Recipients
|
Phase 3 | |
Active, not recruiting |
NCT02936505 -
Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD.
|
N/A |