Clinical trial NCT04242368: Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis
Official title: Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Chronic Rhinosinusitis (Diagnosis)
Keywords: chronic rhinosinusitis
nasal rinses
nasal irrigations
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change in SNOT-22 score
timeFrame: Beginning of week 2 and end of week 3 of the respective treatment period
measure: Mean change in NOSE score
timeFrame: Beginning of week 2 and end of week 3 of the respective treatment period
Secondary outcomes:
measure: Participant-reported compliance with sinus rinses
timeFrame: From the beginning of week 2 to the end of week 3 of the respective treatment period
Other outcomes:
measure: Frequency (by severity) of adverse effects after sinus rinses
timeFrame: From the beginning of week 2 to the end of week 3 of the respective treatment period
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Neelaysh Vukkadala, MD
role: PRINCIPAL_INVESTIGATOR
References: