30
Participants
Start Date
August 31, 2012
Primary Completion Date
October 31, 2013
Study Completion Date
October 31, 2013
Alpha-1 HC 100 mg
Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma. Alpha-1 HC 100 mg inhaled once daily for 21 days for a total of 21 inhaled treatments.
Placebo
Phosphate Buffer Saline with Polysorbate (placebo) composed of the same elements listed for Alpha-1 HC, minus the 50 mg/mL of Alpha-1 HC. Placebo inhaled once daily for 21 days for a total of 21 inhaled treatments.
Alpha-1 HC 200 mg
Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma. Alpha-1 HC 200 mg inhaled once daily for 21 days for a total of 21 inhaled treatments.
UNC at Chapel Hill, Chapel Hill
Medical University of South Carolina, Charleston
The University of Alabama at Birmingham, Birmingham
Rainbow Babies and Children's Hospital, Cleveland
National Jewish Hospital, Denver
Children's Hospital Boston, Boston
Lead Sponsor
Grifols Therapeutics LLC
INDUSTRY