Clinical trial NCT03154541: SynRinse Irrigation Pilot (SIP) Trial
Official title: SynRinse Irrigation Pilot (SIP) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sinusitis, Chronic
Cystic Fibrosis With Other Manifestations
Keywords: Chronic Rhinosinusitis (CRS), Cystic Fibrosis related CRS
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomized, non-blinded single arm cohort study
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Sino-Nasal Outcome Test 22 (SNOT-22)
timeFrame: 1 week
Secondary outcomes:
measure: Sinus bacteria culture
timeFrame: 1 week
measure: Lund-Kennedy Endoscopy Score (LKES)
timeFrame: 1 week
measure: Visual Analog Scale (VAS)
timeFrame: 1 week
measure: Future use questionnaire
timeFrame: 1 week
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: UW
name: Greg Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: