Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis

NCT04242368 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: IRB-53836
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

chronic rhinosinusitis; nasal rinses; nasal irrigations

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Participant-reported compliance with sinus rinses

  From the beginning of week 2 to the end of week 3 of the respective treatment period

Other Outcomes (1)

• Frequency (by severity) of adverse effects after sinus rinses

  From the beginning of week 2 to the end of week 3 of the respective treatment period

Study Arms (2)

Isotonic rinse, then hypertonic rinse

ACTIVE COMPARATOR

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; Drug: Hypertonic Nasal Wash; Drug: Fluticasone Propionate

Hypertonic rinse, then isotonic rinse

EXPERIMENTAL

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; Drug: Hypertonic Nasal Wash; Drug: Fluticasone Propionate

Interventions

Isotonic saline DRUG

Nasal isotonic saline irrigation (240 mL, 0.9% NaCl) administered through nasal rinse bottle.

Hypertonic rinse, then isotonic rinse; Isotonic rinse, then hypertonic rinse

Hypertonic Nasal Wash DRUG

Nasal hypertonic saline irrigation (240 mL, 1.8% NaCl) administered through nasal rinse bottle.

Hypertonic rinse, then isotonic rinse; Isotonic rinse, then hypertonic rinse

Fluticasone Propionate DRUG

Fluticasone nasal spray administered two sprays to each nare twice a day

Also known as: Flonase

Hypertonic rinse, then isotonic rinse; Isotonic rinse, then hypertonic rinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Disease

Interventions

Sodium Chloride; Fluticasone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Neelaysh Vukkadala, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Otolaryngology - Head and Neck Surgery

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)