Investigation of Kinetic Oscillation Stimulation by the Chordate System S101 in the Treatment of Non Allergic Rhinitis

Not Applicable

Completed

• Conditions: Nasal Congestion; Non-allergic Rhinitis
• Interventions: Device: Chordate S101; Device: Chordate S101 Placebo

• Registration Number: NCT03399721
• Lead Sponsor: Chordate Medical

Brief Summary

This is an interventional, multicenter, double-blind, placebo-controlled trial in which patients diagnosed with non-allergic rhinitis will be randomized to either intranasal stimulation, or placebo treatment with the Chordate System at two occasions.

Detailed Description

This is a double-blind, placebo-controlled, multi-center study in which patients diagnosed with non-allergic rhinitis will receive intranasal stimulation with the Chordate System at two occasions. Objectives are to evaluate the efficacy of the procedure in reducing disease specific symptoms such as nasal congestion, rhinorrhea, nasal itching and sneezing, but also to investigate the influence on quality of life, safety and tolerability.

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-16
• Study Start: 2018-05-07
• Status Verified: 2022-07
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

Inclusion Criteria

1. Patients with persistent (>12w) symptoms of non-allergic rhinitis dominated by nasal congestion (± secretion) for an average of at least 1 h per day for at least 5 days during a period of 14 days.
2. Having nasal congestion as major symptom, and a median nasal congestion score of at least 2 (scale 0-3)
3. Male or female 18 - 65 years
4. Judged by the Investigator as suitable for participation in the study without safety concerns based on medical history and physical examination.
5. Willing and able to provide written informed consent prior to participation in the clinical investigation
6. Willing and able to comply with all study related procedures

Exclusion Criteria

1. Patients with Allergic rhinitis, demonstrated by either positive skin prick test, Phadiatop or RAST during the last year.
2. Ongoing respiratory tract infection including nasal cavity at inclusion
3. Systemic steroid treatment less than 4 weeks before the inclusion in the study
4. Patients with a history of nasal surgery like: septoplasty, cosmetic surgery, conchal surgery or any other nasal surgery except closed reposition for nasal fracture during last year
5. History of frequent nose bleeds or a condition that increases the risk of excessive bleeding
6. Pronounced anterior septal deviation or other significant nasal pathology at endoscopic examination
7. Current malignancy of any kind
8. Known allergy to polyvinylchloride or medicinal liquid paraffin
9. Any disease, condition (medical or surgical) or drug or alcohol abuse which, in the opinion of the investigator, might compromise the study results, or would place the patient at increased risk.
10. Any implant with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulation, spinal stimulator, bone growth stimulator, or cochlear implant or any other implant in the head-, and neck region.
11. Previous treated with radiation on the face, head or neck regions
12. Female patients who are pregnant or become pregnant at any time from inclusion of the study until end of the 8 week follow-up visit
13. Received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chordate S101 Active	Chordate S101	Active treatment With Device Chordate S101
Chordate S101 Placebo	Chordate S101 Placebo	Placebo treatment With Device Chordate S101

Primary Outcome Measures

Name	Time	Method
Nasal congestion	3 month	The primary performance endpoint is the responder rate based on the change in the weekly median nasal congestion score (taken from Total Nasal Symptom Score (TNSS)) from baseline to the 3 month follow-up visit

Trial Locations

Locations (13)

Charles University Faculty of Medicine in Hradec Králové; 🇨🇿 Hradec Králové, Czechia

Hospital Pardubice; 🇨🇿 Pardubice, Czechia

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Charles University Motol University Hospital; 🇨🇿 Prag, Czechia

Tampere University Hospital; 🇫🇮 Tampere, Finland

Aristotle University; 🇬🇷 Thessaloniki, Greece

Fondazione Policlinico A Gemelli; 🇮🇹 Rome, Italy

Academisch Medisch Centrum Amsterdam; 🇳🇱 Amsterdam, Netherlands

University Hospital Birmingham; 🇬🇧 Birmingham, United Kingdom

Guys Hospital, Greate Maze Pond; 🇬🇧 London, United Kingdom

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

James Paget University Hospital; 🇬🇧 Great Yarmouth, United Kingdom

Kuopio University Hospital; 🇫🇮 Kuopio, Finland