Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
Completed
FDA Office of Orphan Products Development
Phase 1/Phase 2
2001-09-01
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.
Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics
Terminated
Mallinckrodt
Phase 3
2002-01-01
The purpose of this study is to determine the effect of nitric oxide for inhalation on the
duration of mechanical ventilation in pediatric patients with AHRF.
6-Methyl-Prednisolone for Multiple Organ Dysfunction Syndrome
Unknown status
Pfizer
Phase 4
2005-08-01
Background: Systemic corticosteroids are considered in patients with an adverse clinical
course suffering from conditions like the acute respiratory distress syndrome (ARDS) and
septic shock. Treated patients not only show improved respiratory function, but also
hemodynamic status and overall multiple organ dysfunction score.
Objective: To evaluate the safety and effectiveness of 6-methyl-prednisolone on the clinical
course of multiple organ dysfunction syndrome (MODS).
Design: Multi-center, double-blind, randomized, placebo-controlled.
Intervention: Intravenous administration of 6-methyl-prednisolone or placebo (aqueous
solution). The duration of the study medication administration protocol is 32 days (1).
Primary Endpoints:
1. All cause Intensive Care Unit (ICU) and 28-day mortality
2. Organ dysfunction score on days 4, 7, 14, and 28 of the protocol.
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