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Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis

NCT04242368 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2021-03-18

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Neelaysh Vukkadala, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2021-07-01
Completion
2021-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04242368 on ClinicalTrials.gov