Pilot Randomized Controlled Trial Evaluating the Effect of Hypertonic Saline With and Without Hyaluronic Acid in Reducing Inflammation in Cystic Fibrosis.
Stable CF patients older than 6 years of age and with a FEV1pred. >40%
Interventions
Patients were randomized to one of the treatment arms, Hypertonic saline (HS) or HS+hyaluronic acid (HA), to be administered twice a day at home.
Outcome measures
Clinical data, inflammatory markers (IL-1beta, IL-6, IL-8, IL-10, TNF-alpha, VEGF) in sputum, and judgments on the tolerability and pleasantness were collected at the beginning and after 28 days.
Main results
HA+HS had no significant effect on inflammatory markers versus HS alone, as shown by broad confidence intervals. In the HS+HA group, the highest decrement from baseline values was observed for IL-1beta (-58.8%) followed by VEGF (-49.9%), whereas in the HS group a significant increment of IL-10 levels (+83.0%; p = 0.011) was the only significant finding. Prevalence of unfavorable scores was 36.8% in HA+HS versus 55% in HS group (p = 0.207); no significant differences were detected in the prevalence of moderate/severe symptoms of cough, saltiness, and throat irritation in pulmonary functions tests after 28 days.
Authors' conclusions
HS+HA administration in CF patients does not show any significant effects on lung inflammation and function as compared to HS alone.