8
Participants
Start Date
January 31, 2010
Primary Completion Date
March 31, 2013
Study Completion Date
March 31, 2013
Dexamethasone USP Micronized
The dose for dexamethasone is 30 mg/day for patients \< 60 kg and 40 mg/day for patients \> 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
Prednisone
Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients \> 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients \< 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Weill Medical College, Cornell University, New York
University of Pittsburgh Presbyterian and Shadyside Hospital, Pittsburgh
Children's Hospital of Philadelphia, Philadelphia
University of Pennsylvania, Philadelphia
University of Maryland, Baltimore
Johns Hopkins Hospital, Baltimore
University of North Carolina Hospitals, Chapel Hill
Duke University, Durham
Case Western Reserve University, Cleveland
Cleveland Clinic Foundation, Cleveland
University of Wisconsin, Madison
Gundersen Clinic, La Crosse
Tulane University, New Orleans
The University of Oklahoma Health Sciences Center, Oklahoma City
University of Washington Medical Center, Seattle
Massachusetts General Hospital, Boston
Brigham & Women's Hospital, Boston
Children's Hospital Boston, Boston
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Carelon Research
OTHER