Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis
NCT ID: NCT04242368
Last Updated: 2021-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2020-07-01
2021-07-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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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.
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
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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. SNOT-22 score \>/= 20
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Neelaysh Vukkadala
Resident Physician, Department of Otolaryngology - Head and Neck Surgery
Principal Investigators
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Neelaysh Vukkadala, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Stanford, California, United States
Countries
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Other Identifiers
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IRB-53836
Identifier Type: -
Identifier Source: org_study_id
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