Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

Official title:

Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04242368
• Other study ID #: IRB-53836
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: July 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: March 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis (Diagnosis)
• Sinusitis

Intervention

Drug:
• Isotonic saline
Nasal isotonic saline irrigation (240 mL, 0.9% NaCl) administered through nasal rinse bottle.
• Hypertonic Nasal Wash
Nasal hypertonic saline irrigation (240 mL, 1.8% NaCl) administered through nasal rinse bottle.
• Fluticasone Propionate
Fluticasone nasal spray administered two sprays to each nare twice a day

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency (by severity) of adverse effects after sinus rinses	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
Primary	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.	Beginning of week 2 and end of week 3 of the respective treatment period
Primary	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).	Beginning of week 2 and end of week 3 of the respective treatment period
Secondary	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.	From the beginning of week 2 to the end of week 3 of the respective treatment period