This is a randomized, double-blind, placebo-controlled, dose escalation study to assess the safety and tolerability of 100 mg and 200 mg of inhaled Alpha-1 HC administered once a day for three weeks in people with CF who are 18 years and older. The treatment duration in this study is intended to provide multi-dose safety information prior to proceeding to longer durations of exposure.
ELIGIBILITY
Age:
>= 18 Years
FEV1:
40 - 90 Percent Predicted
P. aeruginosa status:
Not applicable
B. cepacia status:
Negative
Other Primary Eligibility Requirements:
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
AL
The Children's Hospital/University of Alabama at Birmingham (Pediatric), Birmingham, AL, 35233
Contact Information:
Hathorne, Heather Phone: (205) 638-9568 Email: hhathorne@peds.uab.edu
CO
National Jewish Health (Adult), Denver, CO, 80206
Contact Information:
Jones, Marion Phone: (303) 398-1265 Email: jonesm@njhealth.org
University of North Carolina at Chapel Hill (Pediatric), Chapel Hill, NC, 27599
Contact Information:
Barlow, Carol Phone: (919) 966-9146 Email: cbarlow@med.unc.edu
SC
Medical University of South Carolina (Adult), Charleston, SC, 29425
Contact Information:
Warden, Ashley Phone: (843) 792-4349 Email: jonesash@musc.edu
