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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00682500
Other study ID # Pneuma AR-06
Secondary ID
Status Terminated
Phase Phase 3
First received May 20, 2008
Last updated July 23, 2012
Start date May 2008
Est. completion date February 2011

Study information

Verified date July 2012
Source Pneuma Pharmaceuticals Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 332
Est. completion date February 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 85 Years
Eligibility Inclusion Criteria:

1. Respiratory failure due to diffuse infectious pneumonia, aspiration, near drowning, smoke inhalation or industrial gas

2. Less than 48 hours of mechanical ventilation

3. Informed consent

Exclusion Criteria:

1. Pre-existing lung disease

2. coma

3. limited therapeutic goals (do not resuscitate, etc.)

4. failure of another vital organ

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Canada Kingston General Hospital Kingston Ontario
Canada London Health Sciences Centre London Ontario
Canada Royal Columbian Hospital New Westminster British Columbia
Canada Ottawa Hospital Ottawa Ontario
Canada British Columbia Children's Hospital Vancouver British Columbia
Canada Surrey Memorial Hospital Vancouver British Columbia
Canada Vancouver General Hospital Vancouver British Columbia
Israel Haemek Medical Center Jerusalem
Israel Rabin Medical Center Jerusalem
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
New Zealand Starship Children's Hospital Auckland
New Zealand Auckland City Hospital Auckland City Auckland
United States University of Virginia Health Science Center Charlottesville Virginia
United States Northwestern University-Chicago Chicago Illinois
United States INOVA Fairfax Hospital Fairfax Virginia
United States University of Florida Gainesville Florida
United States Penn State University Hershey Pennsylvania
United States Baylor College of Medicine/Texas Children's Hospital Houston Texas
United States Clarian Health, Inc/Methodist Hospital Indianapolis Indiana
United States University of Iowa Iowa City Iowa
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Columbia Medical Center--Pediatrics New York New York
United States West Suburban Hospital Medical Center Oak Park Illinois
United States Creighton University Omaha Nebraska
United States Omaha Children's Hospital Omaha Nebraska
United States Florida Hospital and Florida Children's Hospital Orlando Florida
United States Peoria Pulmonary Associates/OSF St. Francis Hospital Peoria Illinois
United States The Oregon Clinic Portland Oregon
United States Uthscsa/Stvah San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Pneuma Pharmaceuticals Incorporated

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Israel,  Korea, Republic of,  New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Rate 90 days No
Secondary Duration of mechanical ventilation 90 days No
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