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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.

A chronic lung disease developed after OXYGEN INHALATION THERAPY or mechanical ventilation (VENTILATION, MECHANICAL) usually occurring in certain premature infants (INFANT, PREMATURE) or newborn infants with respiratory distress syndrome (RESPIRATORY DISTRESS SYNDROME, NEWBORN). Histologically, it is characterized by the unusual abnormalities of the bronchioles, such as METAPLASIA, decrease in alveolar number, and formation of CYSTS.

A species of PNEUMOVIRUS causing an important respiratory infection in cattle. Symptoms include fever, conjunctivitis, and respiratory distress.

A respiratory distress syndrome in newborn infants, usually premature infants with insufficient PULMONARY SURFACTANTS. The disease is characterized by the formation of a HYALINE-like membrane lining the terminal respiratory airspaces (PULMONARY ALVEOLI) and subsequent collapse of the lung (PULMONARY ATELECTASIS).

A syndrome characterized by outbreaks of late term abortions, high numbers of stillbirths and mummified or weak newborn piglets, and respiratory disease in young unweaned and weaned pigs. It is caused by PORCINE RESPIRATORY AND REPRODUCTIVE SYNDROME VIRUS. (Radostits et al., Veterinary Medicine, 8th ed, p1048)

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