The study, which was the first double-blind, placebo-controlled trial ever conducted in lung transplant patients, tested an inhaled form of cyclosporine, a widely used medicine to prevent organ rejection following a transplant. The study, conducted from 1998 to 2001, was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health.
"Inhaled cyclosporine is the first drug ever to show a decline in the incidence of chronic rejection--the leading cause of death following a lung transplant," says lead author Aldo T. Iacono, M.D., medical director of lung transplantation at the University of Maryland Medical Center and associate professor of medicine at the University of Maryland School of Medicine.
"In our study, the patients who took the inhaled cyclosporine had a two-thirds reduction in chronic rejection compared to those who had the placebo," says Dr. Iacono. "The risk of death, adjusting for all other variables, was five times greater in the group of patients who took the placebo than among those on the inhaled cyclosporine," he adds.
The study included 56 people who had received either a single or a double lung transplant. Within one month following their transplants, they were randomly assigned to take either the inhaled cyclosporine or an inhalable placebo along with traditional anti-rejection therapy. The patients took the inhaled drugs at home three times a week and were followed by the researchers for at least two years.
"The results of this study are exceedingly important for lung transplant patients," says Bartley Griffith, M.D., profe
Contact: Ellen Beth Levitt
University of Maryland Medical Center