Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis

Withdrawn before enrolling · Phase 2/Phase 3

Conditions studied: Chronic Rhinosinusitis (Diagnosis)

In brief

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.

Key facts

Study ID

NCT04242368

Run by

Stanford University

People needed

0

Starts

2020-07-01

Expected to finish

2021-07-01

Last updated by the study team

2021-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of chronic rhinosinusitis with or without polyposis based on the criteria outlined in the American Academy of Otolaryngology-Head and Neck Surgery's Clinical Practice Guideline
• SNOT-22 score >/= 20

You may not qualify if…

• Sinus surgery within 30 days of beginning the study
• Oral steroid use within two weeks of study initiation
• Active sinus exacerbation or sinus exacerbation within two weeks of starting the study
• Allergies or contraindications to fluticasone nasal spray

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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