2
Participants
Start Date
August 31, 2012
Primary Completion Date
July 31, 2013
Study Completion Date
July 31, 2014
Leukine
Participants will receive inhaled rhGM-CSF (Sargramostim, Leukine) at the dose of 250 mcg one time per week for 12 weeks. Following an interim safety evaluation, participants may be entered into a second 12 week treatment period where participants will receive either 250 mcg or 500 mcg once weekly. At the end of any treatment period, participants will be followed for 12 additional weeks in the absence of inhaled rhGM-CSF to evaluate safety and efficacy.
Cincinnati Children's Hospital Medical Center, Cincinnati
Virginia Commonwealth University, Richmond
Virginia Commonwealth University
OTHER
Genzyme, a Sanofi Company
INDUSTRY
Children's Hospital Medical Center, Cincinnati
OTHER