Treprostinil Sodium Inhalation for Patients At High Risk for ARDS

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Respiratory Distress Syndrome, Adult

In brief

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.

Key facts

Study ID

NCT02370095

Run by

University of North Carolina, Chapel Hill

People needed

14

Starts

2015-02-01

Expected to finish

2017-11-07

Last updated by the study team

2019-10-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults age 18-75 years.
• Acute onset need for 4 liters per minute (LPM) or more of supplemental oxygen to maintain Arterial partial pressure of oxygen (PaO2) > 60 mmHg or arterial O2 saturation > 90% by pulse oximetry.
• Acute unilateral pulmonary infiltrate/s on chest radiograph with no clinical evidence of left-sided heart failure. Bilateral infiltrates are acceptable as long as all other inclusion/exclusion criteria are met.

You may not qualify if…

• No consent/inability to obtain consent
• Presence of pulmonary embolism
• Known diffuse alveolar hemorrhage from vasculitis
• Known pre-existing severe obstructive or restrictive lung disease (FEV 1 < 40% predicted, total lung capacity (TLC) < 50 % predicted) or need for long-term supplemental oxygen therapy
• Known significant left ventricular systolic dysfunction with left ventricular ejection fraction (LVEF) < 45% on echocardiogram.
• Mean arterial pressure < 65 mmHg
• Need for norepinephrine or dopamine dose > 12 mcg to maintain mean arterial pressure (MAP) > 65 mmHg
• Severe chronic liver disease (Child-Pugh Score 11-15)
• Moribund patient not expected to survive 24 hours
• Corrected QT interval (QTc) interval > 500 ms on screening electrocardiogram
• Pregnancy or breast feeding (Women of childbearing potential, defined as < 60 years of age, will require pregnancy testing.)
• Burns > 40% total body surface
• Acute Neurological Disease (that may impair the ability to ventilate without assistance)
• Imminent need for intubation or non-invasive ventilation
• Patient is Do Not Resuscitate/Do Not Intubate
• Patient has a tracheotomy
• Patient is currently receiving prostacyclin therapy [Epoprostenol (Flolan or Veletri), Iloprost (Ventavis), Treprostinil (Orenitram, oral) (Remodulin, IV or SC)]
• Patient has a language barrier

Where it is running

• University of North Carolina Hospitals — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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