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A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury

2014-07-23 21:55:04 | BioPortfolio

Summary

The purpose of this study is to determine whether sivelestat will reduce the amount of time a patient must spend on a ventilator and/or increase the chance of survival of patients with acute lung injury.

Description

Acute lung injury often develops as a result of severe infection, sepsis, severe injuries, inhalation of foreign substances into the lungs, or pneumonia. The tissues and blood vessels in the lungs become inflamed, and the body does not receive enough oxygen. Patients with this condition are placed on a ventilator to assist with breathing.

Patients entered into this study will be randomly assigned to one of two treatment groups: a sivelestat group or a placebo group. Once entered into the study, patients are monitored for up to 6 months.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Respiratory Distress Syndrome, Adult

Intervention

Sivelestat

Location

Birmingham
Alabama
United States

Status

Completed

Source

Eli Lilly and Company

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:55:04-0400

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Medical and Biotech [MESH] Definitions

A syndrome characterized by progressive life-threatening RESPIRATORY INSUFFICIENCY in the absence of known LUNG DISEASES, usually following a systemic insult such as surgery or major TRAUMA.

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