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

Chronic Rhinosinusitis Without Nasal Polyps Clinical Trial

— SDX-3101  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04158596
• Other study ID #: SDX-3101
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: October 2020
• Source: SynDermix AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis Without Nasal Polyps
• Nasal Polyps
• Polyps
• Sinusitis

Intervention

Device:
• Vibration Therapy
SDX-3101 is used for drug-free treatment of CRSsNP in adults.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
SynDermix AG	ISS AG

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Saccharine test	Evaluate muco-ciliary clearance time	day 0, week 6, 12 weeks and at 12 months
Other	Reduction in inflammatory markers	Assessed by Biomarkers: IL-1ß, IL-2, IL-4, IL-10, IL-12 and IgE in nasal secretion	day 0, day 14, week 6, 12
Other	Exhaled nasal Nitric Oxide (nNO) levels	only in a subpopulation in selected site/s	day 0, day 14, week 6, 12 and 12 months
Primary	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	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
Secondary	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
Secondary	Need for surgical intervention	Capture surgical intervention	day 14, week 6, 12 and at 6, 9 and 12 months
Secondary	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,
Secondary	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
Secondary	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
Secondary	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
Secondary	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,