Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Isotonic rinse, then hypertonic rinse 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
Nasal isotonic saline irrigation (240 mL, 0.9% NaCl) administered through nasal rinse bottle.
Drug: Hypertonic Nasal Wash
Nasal hypertonic saline irrigation (240 mL, 1.8% NaCl) administered through nasal rinse bottle.
Drug: Fluticasone Propionate
Fluticasone nasal spray administered two sprays to each nare twice a day
Other Names:
|
| Experimental: Hypertonic rinse, then isotonic rinse 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
Nasal isotonic saline irrigation (240 mL, 0.9% NaCl) administered through nasal rinse bottle.
Drug: Hypertonic Nasal Wash
Nasal hypertonic saline irrigation (240 mL, 1.8% NaCl) administered through nasal rinse bottle.
Drug: Fluticasone Propionate
Fluticasone nasal spray administered two sprays to each nare twice a day
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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).
Secondary Outcome Measures
- 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.
Other Outcome Measures
- 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]
The frequency (by severity) of the following patient-reported adverse effects: Nasal burning/pain Headaches Ear pain Sneezing Nose bleeds
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University | Stanford | California | United States | 94304 |
Sponsors and Collaborators
- Stanford University
Investigators
- Principal Investigator: Neelaysh Vukkadala, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-53836