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SynRinse Irrigation Pilot (SIP) Trial

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified May 2017 by Greg Davis, University of Washington
Sponsor:
Information provided by (Responsible Party):
Greg Davis, University of Washington
ClinicalTrials.gov Identifier:
NCT03154541
First received: May 3, 2017
Last updated: May 12, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Sinusitis, Chronic Cystic Fibrosis With Other Manifestations Drug: Synrinse Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Non-randomized, non-blinded single arm cohort study
Masking: No masking
Primary Purpose: Treatment
Official Title: SynRinse Irrigation Pilot (SIP) Trial

Resource links provided by NLM:


Further study details as provided by Greg Davis, University of Washington:

Primary Outcome Measures:
  • Sino-Nasal Outcome Test 22 (SNOT-22) [ Time Frame: 1 week ]
    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 [ Time Frame: 1 week ]
    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) [ Time Frame: 1 week ]
    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) [ Time Frame: 1 week ]
    Determine the tolerability of SYNRINSE as measured on a 10cm VAS

  • Future use questionnaire [ Time Frame: 1 week ]
    Record percentage of subjects willing to use SYNRINSE in the future


Estimated Enrollment: 30
Anticipated Study Start Date: May 2017
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non Cystic Fibrosis (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. 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.

Drug: Synrinse

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.

Experimental: Cystic Fibrosis (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.
Drug: Synrinse

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.


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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03154541

Contacts
Contact: Greg Davis, MD 206 543-5230 gedavis@uw.edu

Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Greg Davis, MD UW
  More Information

Responsible Party: Greg Davis, Associate Professor, Otolaryngology - Head and Neck Surgery, University of Washington
ClinicalTrials.gov Identifier: NCT03154541     History of Changes
Other Study ID Numbers: 1174584
Study First Received: May 3, 2017
Last Updated: May 12, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Greg Davis, University of Washington:
Chronic Rhinosinusitis (CRS), Cystic Fibrosis related CRS

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Sinusitis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 21, 2017