Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
| Lund-Kennedy Endoscopy Score (LKES) |
Not provided
Inclusion Criteria:
Exclusion Criteria
:• Have an allergy to shell fish.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Greg Davis, MD | UW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98144 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
Not provided
Not provided
Non-randomized, non-blinded single arm cohort study
Not provided
Not provided
Not provided
Not provided
|
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 |
| 1 week |
| Visual Analog Scale (VAS) | Determine the tolerability of SYNRINSE as measured on a 10cm VAS | 1 week |
| Future use questionnaire | Record percentage of subjects willing to use SYNRINSE in the future | 1 week |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |