Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis

Stanford University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Chronic Rhinosinusitis (Diagnosis)

Interventions

Isotonic salineDRUG

Nasal isotonic saline irrigation (240 mL, 0.9% NaCl) administered through nasal rinse bottle.

Hypertonic Nasal WashDRUG

Nasal hypertonic saline irrigation (240 mL, 1.8% NaCl) administered through nasal rinse bottle.

Fluticasone PropionateDRUG

Fluticasone nasal spray administered two sprays to each nare twice a day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 2. SNOT-22 score \>/= 20 Exclusion Criteria: 1. Sinus surgery within 30 days of beginning the study 2. Oral steroid use within two weeks of study initiation 3. Active sinus exacerbation or sinus exacerbation within two weeks of starting the study 4. Allergies or contraindications to fluticasone nasal spray

Outcomes

Primary Outcomes

Mean change in SNOT-22 score

Participants will complete the Sinonasal Outcome Test (SNOT)-22, a validated questionnaire for assessing symptoms of chronic rhinosinusitis, before and after completing each intervention. SNOT-22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.

Time frame: Beginning of week 2 and end of week 3 of the respective treatment period

Mean change in NOSE score

Participants will complete the Nasal Obstruction Symptom Evaluation (NOSE), a validated questionnaire for assessing symptoms of nasal obstruction, before and after completing each intervention. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100).

Time frame: Beginning of week 2 and end of week 3 of the respective treatment period

Secondary Outcomes

Participant-reported compliance with sinus rinses

Participants will self-report the number of days in the two week rinsing period in which they used rinses.

Time frame: From the beginning of week 2 to the end of week 3 of the respective treatment period