A Phase 1/2 interventional study of etanercept in Respiratory Distress Syndrome, Adult, Bronchiolitis Obliterans and Pneumonia, sponsored by FDA Office of Orphan Products Development. Completed at 1 site in United States. Open to participants aged 12 Months and older. Per ClinicalTrials.gov, last updated 2015-03-25.
Sponsored by FDA Office of Orphan Products Development · Phase 1/2, Interventional, and Treatment
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.
1,619 studies on the registry are indexed under Respiratory Distress Syndrome; 319 are open to participants now.
This study's enrollment of 15 is below the median of 60 across 973 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →FDA Office of Orphan Products Development is the lead sponsor of 32 studies on the registry; none are open to participants now.
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The record gives a start of Sep 2001 and a completion of Sep 2003. It does not say whether these dates are actual or estimated.
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Studies of the drug tested here: Etanercept
Respiratory Distress Syndrome →
FDA Office of Orphan Products Development