Using a treatment that has been shown to be effective in adults in two previous studies, researchers at the University of North Carolina will begin enrolling infants in a clinical trial to test the effectiveness of inhaled saline as a treatment for cystic fibrosis.
Investigators hope to enroll 150 infants at a minimum age of 4 months in the United States and Canada. They will administer a saltwater aerosol solution nearly two times as salty as the Atlantic Ocean for 15 minutes at least twice a day. The aerosolized saltwater restores the lubricant layer of water that normally coats airway surface but is missing in CF. The water layer promotes the clearance of the naturally occurring mucus the body uses to trap harmful bacteria.
The Cystic Fibrosis Foundation Therapeutics Inc, a nonprofit affiliate of the Cystic Fibrosis Foundation, is funding the trial, “Infant Study of Inhaled Saline” (ISIS). Researchers will receive approximately $3 million for the study over a 5-year period.
Stephanie Davis, MD, one of the three principal investigators, says they hope that inhaled saline will be as effective in infants as in adults, and prevent serious lung disease that in most cases leads to death. “The therapy may also lead to improved quality of life,” she concludes.
