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| Sponsored by: |
Pneuma Pharmaceuticals Incorporated |
|---|---|
| Information provided by: | Pneuma Pharmaceuticals Incorporated |
| ClinicalTrials.gov Identifier: | NCT00682500 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Respiratory Distress Syndrome, Adult |
Drug: Calfactant Drug: Room Air (placebo) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children |
| Estimated Enrollment: | 480 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Calfactant treatment
|
Drug: Calfactant
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.
|
| 2: Placebo Comparator |
Drug: Room Air (placebo)
Administration of 0.5 ml/cm height of air at study entry into the trachea. Repeat dosing at 12 hours if criteria are met
|
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.
Eligibility| Ages Eligible for Study: | 1 Month to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christine Traul, MD | 434-982-3973 | CT6Q@hscmail.mcc.virginia.edu |
| Contact: Douglas Willson, MD | 434-982-1707 | dfw4m@virginia.edu |
Show 27 Study Locations| Study Chair: | Douglas Willson, MD | Univeristy of Virginia Health Sciences Center |
| Study Chair: | Jonathon Truwit, MD | University of Virginia Health Sciences Center |
More Information
| Responsible Party: | University of Virginia Health Science Center ( Douglas Willson, MD ) |
| Study ID Numbers: | Pneuma AR-06 |
| Study First Received: | May 20, 2008 |
| Last Updated: | November 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00682500 |
| Health Authority: | United States: Food and Drug Administration |
|
Pneumonia Aspiration Drowning inhalation |
|
Respiratory Tract Diseases Drowning Lung Diseases Respiration Disorders |
Respiratory Distress Syndrome, Adult Acute respiratory distress syndrome Calfactant Pneumonia |
|
Respiratory System Agents Pathologic Processes Disease Therapeutic Uses |
Syndrome Pharmacologic Actions Pulmonary Surfactants |
