Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis
Status:
Withdrawn
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
Summary
The study aims to determine the safety and efficacy of buffered hypertonic (1.8%) saline
nasal rinses as compared to isotonic saline nasal rinses in patients with chronic
rhinosinusitis (CRS). Evidence from basic science research suggests that hypertonic solutions
may have beneficial effects over isotonic saline rinses; however prior clinical studies on
this topic have been inconclusive and limited due to highly variable inclusion criteria,
large variability in the volume and concentration of irrigation solution, and inconsistent
outcome measures. The goal of the study is to utilize a cross over study design to directly
compare the impact of two different types of saline irrigation.
Primary aim:
Compare the efficacy of buffered hypertonic saline irrigations to buffered isotonic saline
irrigations on patient reported outcome measures of chronic rhinosinusitis symptoms and nasal
obstruction in patients with CRS. Based on in vivo data and prior clinical studies, the
investigators expect participants will experience greater symptom improvement with hypertonic
saline rinses as compared to isotonic saline irrigations.
Hypothesis: Participants will have greater improvement in patient reported outcome measures
(SNOT-22 and NOSE) when using buffered hypertonic sinus irrigations as compared to buffered
isotonic saline irrigations.