Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis

Stanford University

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Chronic Rhinosinusitis (Diagnosis)

Treatments: Drug: Isotonic saline; Drug: Hypertonic Nasal Wash; Drug: Fluticasone Propionate

Study type: Interventional

Funder types: Other

Identifiers

NCT04242368

IRB-53836

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Isotonic rinse, then hypertonic rinse

Active Comparator group

Description:

Participants will start with a one week washout period without rinses. Then they will complete twice daily sinus rinses isotonic saline for two weeks. Next they will have a one week washout period without rinses. Then they will cross-over and complete hypertonic saline sinus rinses for two weeks. Participants will maintain fluticasone treatment throughout the study.

Treatment:

Drug: Fluticasone Propionate

Drug: Hypertonic Nasal Wash

Drug: Isotonic saline

Hypertonic rinse, then isotonic rinse

Experimental group

Description:

Participants will start with a one week washout period without rinses. Then they will complete twice daily sinus rinses of hypertonic saline for two weeks. Next they will have a one week washout period without rinses. Then they will cross-over and complete isotonic saline sinus rinses for two weeks. Participants will maintain fluticasone treatment throughout the study. Fluticasone propionate nasal spray - two sprays to each nare twice a day used for the entire study duration

Treatment:

Drug: Fluticasone Propionate

Drug: Hypertonic Nasal Wash

Drug: Isotonic saline