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SynRinse Irrigation Pilot (SIP) Trial

Primary Purpose

Sinusitis, Chronic, Cystic Fibrosis With Other Manifestations

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Synrinse

About this trial

This is an interventional treatment trial for Sinusitis, Chronic focused on measuring Chronic Rhinosinusitis (CRS), Cystic Fibrosis related CRS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age >= 18
Meet diagnostic criteria for CRS (as defined by the AAO-HNS 2015 Clinical Practice Guidelines for Adult Sinusitis).
Have undergone at least one functional endoscopic sinus surgery, be at least 6 weeks out from surgery, be free of any complication from surgery, and have patent sinuses confirmed by nasal endoscopy.
Have active sinus disease as defined as purulent sinus discharge visualized on nasal endoscopy.
Have more than mild symptoms as determined by the SNOT-22 with a score >20.
Be willing to hold off on standard therapy for chronic sinusitis for 1 week including oral antibiotics and/or oral steroids.
If on topical steroids for greater than 1 month (sprays, drops, or irrigation) these will be continued based on the patients' current use (continued if they are already on them, not initiated if they are not on them).
Must be able to irrigate with large volume/low pressure nasal lavage throughout the study.

Exclusion Criteria

:• Have an allergy to shell fish.

Be able to return for follow up evaluation in 1 week (+ up to 5 days if needed)
Have obstructive nasal polyps
Participants who have used topical antibiotics within 4 weeks of treatment or are actively using them and unwilling to stop
Participants who have used systemic steroids within 4 weeks of treatment
Are unable to give informed consent or complete self-administered questionnaires written in English because of cognitive impairment, language barrier, or severe medical conditions.
Have a terminal illness or significant immune dysfunction.
Have severe or emergent complications from CRS or presence of a sinus tumor.
Patients with Cystic Fibrosis will be recruited in a parallel study.
Participants who are unwilling to discontinue other sinus irrigations treatments and steroid lavage if already on them (including baby shampoo, surfactant, colloid silver, manuka honey, iodine, alcohol, tea tree oil, or any other compound).

Sites / Locations

University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Non Cystic Fibrosis (CF) cohort

Cystic Fibrosis (CF) cohort

Arm Description

The first 10 non-CF subjects will be instructed to once daily irrigate both nasal passages with SynRinse (supplied) delivered via nasal irrigation using the NeilMed® Sinus Rinse™ system for 1 week. No prescription is necessary. The subjects will be asked to refrain from performing any sinus irrigations during the test treatment period with any product including saline. The second set of 10 non-CF subjects (if the study continues to this point) will be instructed to irrigate both nasal passages twice daily (rather than once daily) for one week with SynRinse (supplied). The subjects will be asked to refrain from performing any sinus irrigations during the test treatment period with any product including saline.

The first 5 subjects in the CF cohort will irrigate with with SynRinse delivered via nasal irrigation using the NeilMed Sinus Rinse system for 1 week. The second set of 5 subjects with CF will irrigate both nasal passages twice daily for one week with SynRinse.

Outcomes

Primary Outcome Measures

Sino-Nasal Outcome Test 22 (SNOT-22)

Test pre-treatment SNOT-22 (sinusitis-specific quality of life) and compare to post-treatment SNOT-22 scores to measure any change in disease specific quality of life.

Secondary Outcome Measures

Sinus bacteria culture

Obtain a pre-treatment endoscopic collected culture and a post-treatment endoscopic collected culture to see if the treatment impacts a pathogen detected in the pre-treatment culture.

Lund-Kennedy Endoscopy Score (LKES)

Measure change in pre-treatment LKES and post-treatment LKES to determine if treatment impacts any change in the appearance of the patient's sinuses on endoscopy

Visual Analog Scale (VAS)

Determine the tolerability of SYNRINSE as measured on a 10cm VAS

Future use questionnaire

Record percentage of subjects willing to use SYNRINSE in the future

Full Information

NCT ID

NCT03154541

First Posted

May 3, 2017

Last Updated

October 16, 2018

Sponsor

University of Washington

1. Study Identification

Unique Protocol Identification Number

NCT03154541

Brief Title

SynRinse Irrigation Pilot (SIP) Trial

Official Title

SynRinse Irrigation Pilot (SIP) Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

June 6, 2017 (Actual)

Primary Completion Date

May 30, 2018 (Actual)

Study Completion Date

May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Assess if the use of SYNRINSE can improve short-term subjective and objective outcome measures after one week in patients with active Chronic Rhinosinusitis (CRS) who have had prior sinus surgery.

Detailed Description

SYNRINSE is osmotically balanced and also contains soluble chitosan-argininamide, a modified natural glycopolymer that has a number of properties important to relieving the symptoms of mucus build up and bacterial biofilms. First, SYNRINSE reduces the viscosity of biofilms, the protective environment of infective bacteria that prevents topical antibiotics and other rinses to penetrate to reach the bacterial. By disrupting biofilms, SYNRINSE allows them to be cleared from the sinuses. Second, SYNRINSE has been shown to interact with the polymers comprise mucus, loosening thick, sticky layers and reducing their ability to adhere together and to mucosal surfaces. Third, all of the components in SYNRINSE are biocompatible and soothing to sensitive nasal cavities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sinusitis, Chronic, Cystic Fibrosis With Other Manifestations

Keywords

Chronic Rhinosinusitis (CRS), Cystic Fibrosis related CRS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Non-randomized, non-blinded single arm cohort study

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Non Cystic Fibrosis (CF) cohort

Arm Type

Experimental

Arm Description

Arm Title

Cystic Fibrosis (CF) cohort

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Synrinse

Intervention Description

Non-CF Cohort The first 10 non-CF subjects will be instructed to once daily irrigate both nasal passages with SynRinse (supplied) delivered via nasal irrigation using the NeilMed® Sinus Rinse™ system for 1 week. The subjects will be asked to refrain from performing any sinus irrigations during the test treatment period with any product including saline. The second set of 10 non-CF subjects (if the study continues to this point) will be instructed to irrigate both nasal passages twice daily (rather than once daily) for one week with SynRinse (supplied). The subjects will be asked to refrain from performing any sinus irrigations during the test treatment period with any product including saline. CF Cohort The first 5 subjects in the CF cohort will irrigate with with SynRinse delivered via nasal irrigation using the NeilMed Sinus Rinse system for 1 week. The second set of 5 subjects with CF will irrigate both nasal passages twice daily for one week with SynRinse.

Primary Outcome Measure Information:

Title

Sino-Nasal Outcome Test 22 (SNOT-22)

Description

Test pre-treatment SNOT-22 (sinusitis-specific quality of life) and compare to post-treatment SNOT-22 scores to measure any change in disease specific quality of life.

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Sinus bacteria culture

Description

Obtain a pre-treatment endoscopic collected culture and a post-treatment endoscopic collected culture to see if the treatment impacts a pathogen detected in the pre-treatment culture.

Time Frame

1 week

Title

Lund-Kennedy Endoscopy Score (LKES)

Description

Measure change in pre-treatment LKES and post-treatment LKES to determine if treatment impacts any change in the appearance of the patient's sinuses on endoscopy

Time Frame

1 week

Title

Visual Analog Scale (VAS)

Description

Determine the tolerability of SYNRINSE as measured on a 10cm VAS

Time Frame

1 week

Title

Future use questionnaire

Description

Record percentage of subjects willing to use SYNRINSE in the future

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age >= 18 Meet diagnostic criteria for CRS (as defined by the AAO-HNS 2015 Clinical Practice Guidelines for Adult Sinusitis). Have undergone at least one functional endoscopic sinus surgery, be at least 6 weeks out from surgery, be free of any complication from surgery, and have patent sinuses confirmed by nasal endoscopy. Have active sinus disease as defined as purulent sinus discharge visualized on nasal endoscopy. Have more than mild symptoms as determined by the SNOT-22 with a score >20. Be willing to hold off on standard therapy for chronic sinusitis for 1 week including oral antibiotics and/or oral steroids. If on topical steroids for greater than 1 month (sprays, drops, or irrigation) these will be continued based on the patients' current use (continued if they are already on them, not initiated if they are not on them). Must be able to irrigate with large volume/low pressure nasal lavage throughout the study. Exclusion Criteria :• Have an allergy to shell fish. Be able to return for follow up evaluation in 1 week (+ up to 5 days if needed) Have obstructive nasal polyps Participants who have used topical antibiotics within 4 weeks of treatment or are actively using them and unwilling to stop Participants who have used systemic steroids within 4 weeks of treatment Are unable to give informed consent or complete self-administered questionnaires written in English because of cognitive impairment, language barrier, or severe medical conditions. Have a terminal illness or significant immune dysfunction. Have severe or emergent complications from CRS or presence of a sinus tumor. Patients with Cystic Fibrosis will be recruited in a parallel study. Participants who are unwilling to discontinue other sinus irrigations treatments and steroid lavage if already on them (including baby shampoo, surfactant, colloid silver, manuka honey, iodine, alcohol, tea tree oil, or any other compound).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Greg Davis, MD

Organizational Affiliation

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98144

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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SynRinse Irrigation Pilot (SIP) Trial

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