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Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis

Primary Purpose

Chronic Rhinosinusitis (Diagnosis)

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Isotonic saline
Hypertonic Nasal Wash
Fluticasone Propionate
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis (Diagnosis) focused on measuring chronic rhinosinusitis, nasal rinses, nasal irrigations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Isotonic rinse, then hypertonic rinse

Hypertonic rinse, then isotonic rinse

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.

Full Information

First Posted
January 21, 2020
Last Updated
March 16, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04242368
Brief Title
Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis
Official Title
Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
COVID-19 pandemic, unable to recruit and conduct study procedures per state, local, and university policies.
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis (Diagnosis)
Keywords
chronic rhinosinusitis, nasal rinses, nasal irrigations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isotonic rinse, then hypertonic rinse
Arm Type
Active Comparator
Arm 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.
Arm Title
Hypertonic rinse, then isotonic rinse
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Isotonic saline
Intervention Description
Nasal isotonic saline irrigation (240 mL, 0.9% NaCl) administered through nasal rinse bottle.
Intervention Type
Drug
Intervention Name(s)
Hypertonic Nasal Wash
Intervention Description
Nasal hypertonic saline irrigation (240 mL, 1.8% NaCl) administered through nasal rinse bottle.
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate
Other Intervention Name(s)
Flonase
Intervention Description
Fluticasone nasal spray administered two sprays to each nare twice a day
Primary Outcome Measure Information:
Title
Mean change in SNOT-22 score
Description
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
Title
Mean change in NOSE score
Description
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 Outcome Measure Information:
Title
Participant-reported compliance with sinus rinses
Description
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
Other Pre-specified Outcome Measures:
Title
Frequency (by severity) of adverse effects after sinus rinses
Description
The frequency (by severity) of the following patient-reported adverse effects: Nasal burning/pain Headaches Ear pain Sneezing Nose bleeds
Time Frame
From the beginning of week 2 to the end of week 3 of the respective treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neelaysh Vukkadala, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis

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