A Phase 3 interventional study of Calfactant and Room Air (placebo) in Respiratory Distress Syndrome, Adult, sponsored by Pneuma Pharmaceuticals Incorporated. Terminated at 32 sites in 6 countries. Open to participants aged 12 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-07-24.
Sponsored by Pneuma Pharmaceuticals Incorporated · Phase 3, Interventional, and Treatment
This study will determine if administration of an suspension of calfactant, a lung surfactant, intratracheally in patients with Direct Acute Respiratory Distress Syndrome within 48 hours of requiring mechanical ventilation can decrease the mortality in patients with lethal disease and shorten the course of respiratory failure in patients with sub-lethal disease.
Recruitment limited to direct adult respiratory distress syndrome patients who have been intubated \<48 hours. Origin of ARDS must be infectious pneumonia, aspiration of stomach contents, near drowning, smoke inhalation without pulmonary burn, inhaled industrial gas.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 332 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →This is the only study on the registry with Pneuma Pharmaceuticals Incorporated as lead sponsor.
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Exclusion Criteria:
Calfactant treatment
Drug: Calfactant
Drug: Room Air (placebo)
Intratracheal Instillation of 0.5 mL/cm of height of 60 mg/mL suspension in two aliquots at study entry. Repeat dosing 12 hours later if criteria are met.
Also known as: PneumoSurf
Administration of 0.5 ml/cm height of air at study entry into the trachea. Repeat dosing at 12 hours if criteria are met
Also known as: placebo
Mortality Rate
Time frame: 90 days
Duration of mechanical ventilation
Time frame: 90 days
This study is terminated, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→