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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Chronic Rhinosinusitis Without Nasal Polyps
• Intervention / Treatment: Device: Vibration Therapy

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Schwarzach im Pongau, Austria, 5620
    • Kardinal Schwarzenberg Klinikum GmbH
• Germany
  • Dreieich, Germany, 63303
    • Praxis Dr.med. Decot
  • Essen, Germany, 45355
    • ENT Research Institut für Klinische Studien
  • Heidelberg, Germany, 69120
    • HNO Praxis am Neckar
  • Viernheim, Germany, 68519
    • HNO - Arzt Allergologe Studienzentrum
  • Wuppertal, Germany, 42283
    • Helios Universitätsklinikum Wuppertal
• Switzerland
  • Bern, Switzerland, 3010
    • Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten, Kopf- und Halschirurgie, Inselspital,
  • Zürich, Switzerland, 8091
    • Department of ENT, Head and Neck Surgery Universitätsspital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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,

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: SynDermix AG
• Collaborators: ISS AG
• Investigators: Study Director: Carlos R Camozzi, MD, SynDermix AG

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): October 31, 2020
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Nasal Polyps; Polyps
• Other Study ID Numbers: SDX-3101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No