Respiratory Distress Syndrome, Adult Clinical Trial
Official title:
Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II Study
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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