Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Cystic Fibrosis (CF) Subjects
Status:
Completed
Trial end date:
2018-04-09
Target enrollment:
Participant gender:
Summary
Cystic fibrosis (CF) lung disease is characterized by chronic bacterial colonization and
recurrent infection of the airways. Lowering the airway surface liquid (ASL) salt
concentration has been shown to increase activity of salt sensitive antimicrobial peptides.
Xylitol is a 5-carbon sugar that can lower the ASL salt concentration, thus enhancing innate
immunity. In this study, the investigators propose to test the safety and tolerability of
aerosolized xylitol used daily for 2 weeks in subjects with cystic fibrosis. In a pilot,
2-week study, 60 subjects with cystic fibrosis with an FEV1(Forced expiratory volume in 1
second ) >30% predicted will be randomized to receive aerosolized 7% hypertonic saline (5 ml)
or 15% xylitol, (5 ml) twice a day for 14 days. The primary outcomes will be safety as
assessed by FEV1 change from baseline, adverse events and respiratory symptom score. Outcomes
for trend in efficacy include density of colonization of sputum, time to next exacerbation,
sputum cytokines and revised CF quality of life questionnaire.