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

• ClinicalTrials.gov Identifier: NCT04158596
• Recruitment Status: Withdrawn
• First Posted: November 12, 2019
• Last Update Posted: October 22, 2020
• Sponsor: SynDermix AG
• Collaborator: ISS AG
• Information provided by (Responsible Party): SynDermix AG

Tracking Information

• First Submitted Date: November 5, 2019
• First Posted Date: November 12, 2019
• Last Update Posted Date: October 22, 2020
• Actual Study Start Date: June 1, 2020
• Estimated Primary Completion Date: October 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 6, 2019)

SNOT-20 GAV [ Time Frame: 12 weeks ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 6, 2019)

• Lund-Kennedy Score [ Time Frame: day 0, day 14, week 6, 12 and at 6, 9 and 12 months ]
  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
• Overall disease control [ Time Frame: day 14, week 6, 12 and at 6, 9 and 12 months ]
  Need for systemic medication, steroid or antibiotic, number of days
• Need for surgical intervention [ Time Frame: day 14, week 6, 12 and at 6, 9 and 12 months ]
  Capture surgical intervention
• Ability to perform normal activities [ Time Frame: day 0, day 14, week 6, 12 and at 6, 9 and 12 months, ]
  Measured with the SNOT-20 GAV
• Acceptability of treatment [ Time Frame: day 14, week 6, 12 and at 6, 9 and 12 months ]
  Measurement of Visual Analogue Scale 0 to 5, 0 is unacceptable to 5 fully accepted
• Overall score SNOT-20 [ Time Frame: day 0, day 14, week 6, 12 and at 6, 9 and 12 months ]
  The SNOT-20 has a maximum score of 100 and a minimum score of 0. Higher values represent a worse outcome
• Pain in the face [ Time Frame: day 0, day 14, week 6, 12 and at 6, 9 and 12 months ]
  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)
• Global impression by investigator [ Time Frame: day 0, week 6, 12 and at 12 months, ]
  Measured with Visual Analogue Scale 0 to 10, 0 is unsatisfactory 10 is optimal outcome

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: November 6, 2019)

• Saccharine test [ Time Frame: day 0, week 6, 12 weeks and at 12 months ]
  Evaluate muco-ciliary clearance time
• Reduction in inflammatory markers [ Time Frame: day 0, day 14, week 6, 12 ]
  Assessed by Biomarkers: IL-1β, IL-2, IL-4, IL-10, IL-12 and IgE in nasal secretion
• Exhaled nasal Nitric Oxide (nNO) levels [ Time Frame: day 0, day 14, week 6, 12 and 12 months ]
  only in a subpopulation in selected site/s

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Safety and Efficacy of SDX-3101 for the Treatment of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
• Official Title: 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
• Brief Summary: 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

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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Chronic Rhinosinusitis Without Nasal Polyps

Intervention

Device: Vibration Therapy

SDX-3101 is used for drug-free treatment of CRSsNP in adults.

Study Arms

• Experimental: Treatment
  The applied therapeutic vibrations generated by an acoustic coil have a defined sweeping frequency range.
  Intervention: Device: Vibration Therapy
• Active Comparator: Control
  A control device with a different vibration pattern will be used as comparator intervention
  Intervention: Device: Vibration Therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: October 20, 2020): 0
• Original Estimated Enrollment (submitted: November 6, 2019): 76
• Estimated Study Completion Date: October 31, 2021
• Estimated Primary Completion Date: October 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Germany, Switzerland

Administrative Information

• NCT Number: NCT04158596
• Other Study ID Numbers: SDX-3101
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: SynDermix AG
• Study Sponsor: SynDermix AG
• Collaborators: ISS AG

Investigators

• Study Director: Carlos R Camozzi, MD; SynDermix AG

• PRS Account: SynDermix AG
• Verification Date: October 2020