Calfactant for Direct Acute Respiratory Distress Syndrome - Full Text View

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children

Resource links provided by NLM:

Drug Information available for: Calfactant

U.S. FDA Resources

Further study details as provided by Pneuma Pharmaceuticals Incorporated:

Primary Outcome Measures:

Mortality Rate [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of mechanical ventilation [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	480
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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. Other Name: PneumoSurf
Placebo Comparator: 2	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 Other Name: placebo

Detailed Description:

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:	12 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Respiratory failure due to diffuse infectious pneumonia, aspiration, near drowning, smoke inhalation or industrial gas
Less than 48 hours of mechanical ventilation
Informed consent

Exclusion Criteria:

Pre-existing lung disease
coma
limited therapeutic goals (do not resuscitate, etc.)
failure of another vital organ

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682500

Contacts

Contact: Douglas Willson, MD

434-982-1707

dfw4m@virginia.edu

Show 32 Study Locations

Sponsors and Collaborators

Pneuma Pharmaceuticals Incorporated

Investigators

Study Chair:	Douglas Willson, MD	Univeristy of Virginia Health Sciences Center
Study Chair:	Jonathon Truwit, MD	University of Virginia Health Sciences Center

More Information

No publications provided

Responsible Party:	Douglas Willson, MD, University of Virginia Health Science Center
ClinicalTrials.gov Identifier:	NCT00682500 History of Changes
Other Study ID Numbers:	Pneuma AR-06
Study First Received:	May 20, 2008
Last Updated:	May 25, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pneuma Pharmaceuticals Incorporated:

Pneumonia
Aspiration
Drowning
inhalation

Additional relevant MeSH terms:

Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases

Infant, Newborn, Diseases
Lung Injury
Calfactant
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012