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Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242368
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Neelaysh Vukkadala, Stanford University

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
Chronic Rhinosinusitis (Diagnosis) Drug: Isotonic saline Drug: Hypertonic Nasal Wash Drug: Fluticasone Propionate Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


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 Name: Flonase

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 Name: Flonase




Primary Outcome Measures :
  1. Mean change in SNOT-22 score [ Time Frame: 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.


  2. Mean change in NOSE score [ Time Frame: 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 :
  1. Participant-reported compliance with sinus rinses [ Time Frame: 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:
  1. Frequency (by severity) of adverse effects after sinus rinses [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242368


Contacts
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Contact: Neelaysh Vukkadala, MD 650-725-6500 nvukkada@stanford.edu
Contact: Peter H Hwang, MD 650-725-6500 hwangph@stanford.edu

Locations
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United States, California
Stanford University
Stanford, California, United States, 94304
Contact: Neelaysh Vukkadala, MD    408-759-4549    nvukkada@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Neelaysh Vukkadala, MD Stanford University
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Responsible Party: Neelaysh Vukkadala, Resident Physician, Department of Otolaryngology - Head and Neck Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT04242368    
Other Study ID Numbers: IRB-53836
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Neelaysh Vukkadala, Stanford University:
chronic rhinosinusitis
nasal rinses
nasal irrigations
Additional relevant MeSH terms:
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Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents