The findings come from the same study that previously found that inhaled cyclosporine improved survival and extended periods of chronic rejection-free survival in lung transplant patients. Those results were published in The New England Journal of Medicine in January 2006.
"Many lung transplant patients develop chronic rejection of the new lung--it is the Achilles heel of the transplant process," said lead researcher Aldo 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 Baltimore. "Typically, patients experience a progressive, inexorable decline in lung function, most likely because of this chronic rejection and infections. This finding that aerosolized cyclosporine preserves lung function bolsters our previous findings that the drug reduces chronic rejection of the lung."
The new study looked at 58 lung transplant patients, who were randomly assigned to inhale either 300 mg of aerosol cyclosporine or aerosol placebo three days a week for the first two years after their transplant. Both groups received oral anti-rejection medicines.
Patients who received the placebo experienced a decline in lung function that was four times as great as those who inhaled the cyclosporine. There was no difference in the rate of acute rejection of the lung (rejection occurring in the first few weeks after surgery) between the two groups.
"Since the early 1990s we have been studying inhaled cyclosporine in lung transplant patients after they experience chronic rejection, but this is the first trial in which inhaled cyclosporine was used soon after the lung transplant occurred, before chronic rejection sets in," Dr. Iacono said.
About 1,700 lung transplants are done at 150 centers around the world each year, but they are among the riskiest types of transplant surgery. Almost half of recipients die within three years, and the long-term survival rate has not changed much in the last 20 years.
Dr. Iacono said that the data on the drug's impact on survival and chronic rejection were presented to the U.S. Food and Drug Administration in June 2005, and that the FDA requested further studies. "I am hoping that the lung transplant community can work together to organize a multi-center trial," he said. "If we find promising results from a new, bigger, trial, and the drug becomes readily available, it could make a big difference for lung transplant patients."