Infections

All Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Immune System Diseases

Rare Diseases

Communicable Diseases

Epstein-Barr Virus Infections

Bronchiolitis

Virus Diseases

Paramyxoviridae Infections

Bronchiolitis Obliterans Syndrome

Bronchiolitis Obliterans

Syndrome

Disease Attributes

Bronchitis

Respiratory Tract Infections

Bronchial Diseases

Respiratory Tract Diseases

Lung Diseases

Lung Diseases, Obstructive

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Pneumonia

Organizing Pneumonia

Graft vs Host Disease

Mononegavirales Infections

RNA Virus Infections

Bronchiolitis Obliterans Organizing Pneumonia

Homologous Wasting Disease

Jens T Gottlieb, MD

Ilka Engelmann, MD

The present study was conducted to study the impact community acquired respiratory virus (CARV) infections in an outpatient setting on graft function of lung transplant recipients. The study was aimed to identify risk factors for CARV infections.

The study was further intended to investigate an association of Epstein-Barr virus (EBV), cytomegalovirus (CMV) and human adenovirus (HAdV) with the development of BOS and to identify risk factors for virus detection in blood.

Informed consent was obtained from the LTx recipients and the study was approved of by the institutional review board of Hannover medical school.

LTx recipients are screened for CARV infections during the cold season (end October until end April) in a single-centre outpatient clinic. Symptoms of upper (URTI) and lower respiratory tract infections (URTI) are recorded by questionnaires and findings.

Nasopharyngeal and oropharyngeal swabs (NOS) were performed to detect RV-antigens by immunofluorescence testing (IFT) of respiratory-syncytial virus (RSV), adenovirus, parainfluenza (PIV), influenza and cultures for CARV are performed. BAL was performed when clinically indicated and processed by IFT. Multiplex-PCR to detect 14 CARV are processed in symptomatic patients.

In addition blood samples are monitored at each contact to investigate an association of Epstein-Barr virus (EBV), cytomegalovirus (CMV) and human adenovirus (HAdV) with the development of BOS and to identify risk factors for virus detection in blood.

Nasopharyngeal and oropharyngeal swabs

bronchoalveolar lavage

blood samples

Surveillance Study of Viral Infections Following Lung Transplantation

Season Surveillance Study of Viral Infections in Lung Transplant Recipients

Department of Pulmonology

Department of Virology

Hannover Medical School

Diseases and Abnormalities at or Before Birth

Wounds and Injuries

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Necrosis

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Acute Lung Injury

Lung Injury

Respiration Disorders

Premature Birth

Infant, Premature, Diseases

Infant, Newborn, Diseases

Respiratory Distress Syndrome, Infant

Acute Respiratory Distress Syndrome

Acute Graft Versus Host Disease

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Gastrointestinal Agents

All Drugs and Chemicals

Etanercept

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Immunosuppressive Agents

Immunologic Factors

etanercept

Kenneth Cooke, M.D.

The purpose of this study is to determine the effects of etanercept, and define the toxicity, when administered to patients with acute non-infectious lung injury (idiopathic pneumonia syndrome, IPS) and with subacute pulmonary dysfunction after allogeneic stem cell transplantation.

Over the last 2 decades, allogeneic bone marrow transplantation (BMT) has emerged as an important treatment option for a number of malignant and non-malignant disorders. Unfortunately, pulmonary dysfunction remains a frequent and severe complication of allogeneic BMT. One of the main chemicals felt to cause lung damage is Tumor Necrosis Factor (TNF). Etanercept is an experimental drug that attempts to block TNF lung damage. Patients will undergo blood tests, x-rays, and a bronchoscopy with broncho-alveolar lavage prior to treatment with etanercept to check for infection. If no infection is evident after 24 hours, the etanercept will be started and administered twice weekly for 4 weeks by subcutaneous injection. There will be weekly blood tests and bronchoscopy after the last drug dose.

Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation

FDA Office of Orphan Products Development

Thoracic Injuries

Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.

Gregory A Yanik, MD

The purpose of this study is to determine the effectiveness of etanercept in the treatment of patients with sub-acute lung injury following a bone marrow transplant. This study will also examine the toxicity of treatment with etanercept as well as whether there is an improved quality of life in these patients.

Lung or breathing problems can develop several months to years following a bone marrow transplant. In some cases, these breathing problems develop without any signs of germs or infection in the lungs. The name for this type of breathing problem is called "Sub-Acute Lung Injury". Sub-acute lung injury often develops many months, even years following a bone marrow transplant. It is often characterized by shortness of breath, cough, wheezing and fatigue.

Sub-acute lung injury can either lead to the formation of scar tissue in the lungs (making it difficult to take deep breaths), or it can cause the lungs to get weak (making people feel out of breath easily). Approximately 25 - 50% of patients with sub-acute lung injury may eventually die from the damage in their lungs. Typically, such patients die from infections that develop inside the damaged lungs.

In this study, treatment with an experimental drug called Etanercept will be used. (Enbrel). The physicians feel there is the possibility that Etanercept may help improve breathing. Breathing ability will be assessed prior to treatment as well as during and after treatment so that comparisons can be made.

Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant

Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II Study

Response was defined as a greater than or equal to 10% improvement in the absolute value for FEV1 (for obstructive defects) or FVC (for restrictive defects), and DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) .

To evaluate the toxicity of etanercept therapy in patients with sub-acute lung injury \> 100 days post transplant, the percent incidence of grade 3 to 4 adverse events among evaluable patients was calculated.

University of Michigan Rogel Cancer Center

Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.

Etanercept for lung injury

Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.

Etanercept Treatment

Age, Continuous

Sex: Female, Male

AML/MDS/MF

Acute Lymphoblastic Leukemia (ALL)

Chronic Mylogenous Leukemia (CML)

NHL/CLL

Myeloma

Nonmalignant

Diagnosis

HLA Matched

Mismatch

Human Leukocyte Antigen (HLA) Match

Pluripotent Stem Cell (PSC)

Marrow

Cell Source

Matched Related Donor (MRD)

Unrelated Donor (URD)

Donor Type

Chronic Graft Versus Host Disease (GVHD) Present

Restrictive

Obstructive

Lung Injury Pattern

All patients enrolled that received at least one scheduled dose.

Gregory Yanik, M.D.

≥10% Improvement in FEV1 / FVC

≥10% Improvement in DLCO

34 subjects were enrolled. Thirty-one of 34 subjects were evaluable for response, with three subjects completing \<50% of scheduled dosing.

Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surveillance Study of Viral Infections Following Lung Transplantation	NCT00701922	Lung Transplant... Bronchiolitis O... Epstein-Barr Vi... Paramyxoviridae...		18 Years - 70 Years	Hannover Medical School
Surveillance Study of Viral Infections Following Lung Transplantation	NCT00701922	Lung Transplant... Bronchiolitis O... Epstein-Barr Vi... Paramyxoviridae...		18 Years - 70 Years	Hannover Medical School
Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation	NCT00029328	Respiratory Dis... Bronchiolitis O... Pneumonia	etanercept	12 Months -	FDA Office of Orphan Products Development
Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant	NCT00141726	Lung Injury, Ac... Respiratory Dis... Bronchiolitis O...	Etanercept	6 Years -	University of Michigan Rogel Cancer Center
Surveillance Study of Viral Infections Following Lung Transplantation	NCT00701922	Lung Transplant... Bronchiolitis O... Epstein-Barr Vi... Paramyxoviridae...		18 Years - 70 Years	Hannover Medical School

Spots Global Cancer Trial Database for bronchiolitis obliterans