Clinical trial NCT04158596: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Rhinosinusitis Without Nasal Polyps
Lead sponsor: SynDermix AG
Sponsor class: INDUSTRY
Collaborators: name: ISS AG
First posted: 2019-11-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: SNOT-20 GAV
timeFrame: 12 weeks
Secondary outcomes:
measure: Lund-Kennedy Score
timeFrame: day 0, day 14, week 6, 12 and at 6, 9 and 12 months
measure: Overall disease control
timeFrame: day 14, week 6, 12 and at 6, 9 and 12 months
measure: Need for surgical intervention
timeFrame: day 14, week 6, 12 and at 6, 9 and 12 months
measure: Ability to perform normal activities
timeFrame: day 0, day 14, week 6, 12 and at 6, 9 and 12 months,
measure: Acceptability of treatment
timeFrame: day 14, week 6, 12 and at 6, 9 and 12 months
measure: Overall score SNOT-20
timeFrame: day 0, day 14, week 6, 12 and at 6, 9 and 12 months
measure: Pain in the face
timeFrame: day 0, day 14, week 6, 12 and at 6, 9 and 12 months
measure: Global impression by investigator
timeFrame: day 0, week 6, 12 and at 12 months,
Other outcomes:
measure: Saccharine test
timeFrame: day 0, week 6, 12 weeks and at 12 months
measure: Reduction in inflammatory markers
timeFrame: day 0, day 14, week 6, 12
measure: Exhaled nasal Nitric Oxide (nNO) levels
timeFrame: day 0, day 14, week 6, 12 and 12 months
Locations:
city: Schwarzach im Pongau
country: Austria
facility: Kardinal Schwarzenberg Klinikum GmbH
city: Dreieich
country: Germany
facility: Praxis Dr.med. Decot
city: Essen
country: Germany
facility: ENT Research Institut für Klinische Studien
city: Heidelberg
country: Germany
facility: HNO Praxis am Neckar
city: Viernheim
country: Germany
facility: HNO - Arzt Allergologe Studienzentrum
city: Wuppertal
country: Germany
facility: Helios Universitätsklinikum Wuppertal
city: Bern
country: Switzerland
facility: Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten, Kopf- und Halschirurgie, Inselspital,
city: Zürich
country: Switzerland
facility: Department of ENT, Head and Neck Surgery Universitätsspital Zürich
Study officials:
affiliation: SynDermix AG
name: Carlos R Camozzi, MD
role: STUDY_DIRECTOR
References: