Successful Therapy for Adults to Begin Clinical Trials in Infants in 2008
November 9, 2007
Early next year, researchers at the University of North Carolina (UNC) at Chapel Hill will begin enrolling infants in a clinical trial to test the effectiveness of inhaled saline as a treatment for cystic fibrosis lung disease. Inhaled saline solution is salty saltwater—almost twice as salty as the Atlantic Ocean.
This study represents the first time that inhaled saline will be tested in infants over an extended period of time. This treatment has been effective in adults with CF, as proven by two earlier studies—one by researchers at UNC and one done in Australia, funded by the Cystic Fibrosis Foundation. Both studies were published in The New England Journal of Medicine in January 2006.
The clinical trial, called “Infant Study of Inhaled Saline” or ISIS, is being funded by Cystic Fibrosis Foundation Therapeutics, Inc., a non-profit affiliate of the Cystic Fibrosis Foundation. UNC will receive approximately $3 million in funding for the study over a five-year period.
The study seeks to enroll 150 infants at a minimum age of four months at 15 sites in the United States and one site in Canada. By inhaling a saltwater aerosol solution for 15 minutes at least twice a day, it is hoped the infants should be able to avoid a significant part of the damage the disease causes to their lungs.
To read the full press release, click here.