NCT04242368

Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Rhinosinusitis (Diagnosis)

Interventions

Type	Name	Description
DRUG	Isotonic saline	Nasal isotonic saline irrigation (240 mL, 0.9% NaCl) administered through nasal rinse bottle.
DRUG	Hypertonic Nasal Wash	Nasal hypertonic saline irrigation (240 mL, 1.8% NaCl) administered through nasal rinse bottle.
DRUG	Fluticasone Propionate	Fluticasone nasal spray administered two sprays to each nare twice a day

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2020-01-27
• Last updated: 2021-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study