Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis

Phase 2

Withdrawn

• Conditions: Chronic Rhinosinusitis (Diagnosis)
• Interventions: Drug: Isotonic saline; Drug: Hypertonic Nasal Wash; Drug: Fluticasone Propionate

• Registration Number: NCT04242368
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Study Start: 2020-07-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-18
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hypertonic rinse, then isotonic rinse	Fluticasone Propionate	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
Hypertonic rinse, then isotonic rinse	Hypertonic Nasal Wash	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
Isotonic rinse, then hypertonic rinse	Isotonic saline	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.
Isotonic rinse, then hypertonic rinse	Hypertonic Nasal Wash	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.
Isotonic rinse, then hypertonic rinse	Fluticasone Propionate	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.
Hypertonic rinse, then isotonic rinse	Isotonic saline	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

Primary Outcome Measures

Name	Time	Method
Mean change in NOSE score	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).
Mean change in SNOT-22 score	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.

Secondary Outcome Measures

Name	Time	Method
Participant-reported compliance with sinus rinses	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States