SynRinse Irrigation Pilot (SIP) Trial

NCT03154541 | Completed Phase 1

• 1 other identifier: STUDY00001280
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinusitis, Chronic; Cystic Fibrosis With Other Manifestations

Keywords

Chronic Rhinosinusitis (CRS), Cystic Fibrosis related CRS

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week

Secondary Outcomes (4)

• Sinus bacteria culture

  1 week

• Lund-Kennedy Endoscopy Score (LKES)

  1 week

• Visual Analog Scale (VAS)

  1 week

• Future use questionnaire

  1 week

Study Arms (2)

Non Cystic Fibrosis (CF) cohort

EXPERIMENTAL

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

Cystic Fibrosis (CF) cohort

EXPERIMENTAL

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

Interventions

Synrinse DRUG

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.

Cystic Fibrosis (CF) cohort; Non Cystic Fibrosis (CF) cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• :• 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).

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98144, United States

Location

MeSH Terms

Conditions

Sinusitis; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Greg Davis, MD

  UW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Otolaryngology - Head and Neck Surgery

Model Details: Non-randomized, non-blinded single arm cohort study

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 16, 2017
• Study Start: June 6, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)