Safety and Efficacy of SDX-3101 for the Treatment of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Study Overview
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Brief Summary
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The purpose of this clinical trial is to assess the safety and efficacy of SDX-3101 for treatment of adult patients with chronic rhinosinusitis without nasal polyps (CRSsNP) by investigating a vibration pattern of SDX-3101 compared to a control

Detailed Description
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Chronic rhinosinusitis (CRS) is a common disease (e.g. 11% of adults in the UK report symptoms of CRS) leading to substantial health and socioeconomic burden with estimated healthcare costs in the USA of $772/patient/year (2011). CRS is characterised by the long-term presence of multiple symptoms including facial pain/pressure in about 80% of CRS patients. Factors contributing to the pathophysiology of adult CRS include allergies, bacterial biofilms, asthma and exposure to various environmental pollutants. Computed tomography (CT) scans are often used to identify mucosal thickening and to identify any comorbid factors such as anatomic abnormalities. It is known from the literature that low vibration frequency can improve blood flow, significantly reduce inflammation, and increase the fibroblast activity [13]. Therefore, SynDermix AG created the innovative high-technology, portable medical device SDX-3101 targeting a disease with high unmet medical need. The device offers a drug-free or eventually an add on treatment complying with the maximum demands of safety for the patients potentially avoiding undesirable drug effects or surgery. SDX-3101 is indicated for treatment of CRSsNP in adults

Official Title
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Randomised, Double-blind, Multi-centre, Clinical Trial to Assess the Safety and Efficacy of SDX-3101, an Innovative Vibration Therapy Portable Device for the Treatment of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) in Adult Patients

Conditions
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Chronic Rhinosinusitis Without Nasal Polyps

Intervention / Treatment
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* Device: Vibration Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male or female subjects between 18 and 70 years old Diagnosed history of chronic rhinosinusitis without nasal polyps (CRSsNP) defined as per EPOS Guidelines. Moderate to severe baseline SNOT-20 GAV score (> 20) Willingness to stop nasal saline irrigation and drug therapy for CRSsNP (restart later on possible) Exclusion Criteria: Subjects with local pathology that would compromise the ability to either administer the device or assess the benefits/risks (e.g. mucocele, antrochoanal polyp, facial trauma, radiation injury, or birth defect) Systemic corticosteroids if not stop for 14 days before study enrolment Subjects suffering from insufficiently controlled asthma Subjects suffering from insufficiently controlled allergic rhinitis (AR) Subjects with prior sinus operations within the last 4 months Subjects with known primary ciliary dyskinesia/cystic fibrosis Subjects with serious underlying medical condition Ongoing oncological treatments Known hypersensitivity to materials in direct contact with the skin Metal or metal-like implant (incl. ceramic) located in the head or neck area. Unremovable hearing aids Patients with implanted cardiac pace-maker Women who are pregnant or breast feeding Known or suspected non-compliance, drug or alcohol abuse, Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>The applied therapeutic vibrations generated by an acoustic coil have a defined sweeping frequency range. | Device: Vibration Therapy<br>* SDX-3101 is used for drug-free treatment of CRSsNP in adults.<br>|
| Active Comparator: Control<br>A control device with a different vibration pattern will be used as comparator intervention | Device: Vibration Therapy<br>* SDX-3101 is used for drug-free treatment of CRSsNP in adults.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNOT-20 GAV | The primary endpoint is the change in subjective symptoms as quantified by the German validated disease-specific 20-item Sino-nasal Outcome Test (SNOT-20 GAV) after 12 weeks. Superiority is defined as more than minimal clinically important difference (MCID) of 8.9 points to active control of SNOT-20 score at 12 weeks. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lund-Kennedy Score | We use the Lund-Kennedy endoscopic scoring system to measure the patient's nasal cavity based on there were edema, vesicles, adhesions, scars and polyps | day 0, day 14, week 6, 12 and at 6, 9 and 12 months | 
| Overall disease control | Need for systemic medication, steroid or antibiotic, number of days | day 14, week 6, 12 and at 6, 9 and 12 months | 
| Need for surgical intervention | Capture surgical intervention | day 14, week 6, 12 and at 6, 9 and 12 months | 
| Ability to perform normal activities | Measured with the SNOT-20 GAV | day 0, day 14, week 6, 12 and at 6, 9 and 12 months, | 
| Acceptability of treatment | Measurement of Visual Analogue Scale 0 to 5, 0 is unacceptable to 5 fully accepted | day 14, week 6, 12 and at 6, 9 and 12 months | 
| Overall score SNOT-20 | The SNOT-20 has a maximum score of 100 and a minimum score of 0. Higher values represent a worse outcome | day 0, day 14, week 6, 12 and at 6, 9 and 12 months | 
| Pain in the face | Measured on a 4-point scale, (0=no symptoms; 1=mild symptoms present, but not troublesome; 2=moderate symptoms that were frequently troublesome but not sufficiently so to interfere with normal daily activities or sleep; 3=severe symptoms that interfered with normal daily activities or sleep) | day 0, day 14, week 6, 12 and at 6, 9 and 12 months | 
| Global impression by investigator | Measured with Visual Analogue Scale 0 to 10, 0 is unsatisfactory 10 is optimal outcome | day 0, week 6, 12 and at 12 months, |