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Treprostinil Sodium Inhalation for Patients At High Risk for ARDS

NCT02370095 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-10-01

Study results available
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Summary

Acute Respiratory Distress Syndrome (ARDS) is a rapidly progressing lung disease caused by a number of factors including pneumonia, sepsis and acute trauma that leads to reduced lung function and breathlessness. There are no pharmacological treatments approved for the treatment of ARDS. This pilot trial will study the safety and efficacy of Treprostinil sodium by inhalation for preventing the progression of acute hypoxemic respiratory failure to positive pressure ventilation and/or ARDS in patients at high risk.

Conditions

  • Respiratory Distress Syndrome, Adult

Interventions

DRUG

Treprostinil Inhalation Solution

Treprostinil inhalation solution administered as blinded marketed product

DRUG

Placebo

Supplied by the manufacturer and similar to the active drug but containing no Treprostinil

Sponsors & Collaborators

  • United Therapeutics

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Hubert J Ford, MD · University of North Carolina, Chapel Hill

  • Shannon Carson, MD · University of North Carolina, Chapel Hill

  • Wayne H Anderson, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-10-11
Completion
2017-11-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02370095 on ClinicalTrials.gov