Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis

March 16, 2021 updated by: Neelaysh Vukkadala, Stanford University

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94304
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Isotonic rinse, then hypertonic rinse
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.
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
Other Names:
  • Flonase
Experimental: Hypertonic rinse, then isotonic rinse

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
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
Other Names:
  • Flonase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in SNOT-22 score
Time Frame: Beginning of week 2 and end of week 3 of the respective treatment period

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.
Beginning of week 2 and end of week 3 of the respective treatment period
Mean change in NOSE score
Time Frame: Beginning of week 2 and end of week 3 of the respective treatment period

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).
Beginning of week 2 and end of week 3 of the respective treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant-reported compliance with sinus rinses
Time Frame: From the beginning of week 2 to the end of week 3 of the respective treatment period
Participants will self-report the number of days in the two week rinsing period in which they used rinses.
From the beginning of week 2 to the end of week 3 of the respective treatment period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency (by severity) of adverse effects after sinus rinses
Time Frame: From the beginning of week 2 to the end of week 3 of the respective treatment period

The frequency (by severity) of the following patient-reported adverse effects:

  • Nasal burning/pain
  • Headaches
  • Ear pain
  • Sneezing
  • Nose bleeds
From the beginning of week 2 to the end of week 3 of the respective treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Neelaysh Vukkadala, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

January 21, 2020

First Submitted That Met QC Criteria

January 23, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-53836

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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