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

NCT03399721 | Completed

• 1 other identifier: PR008
• Study Type: interventional
• Target: 279
• Locations: 6 countries
• Sites: 13

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.

Conditions

Nasal Congestion; Non-allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Nasal congestion

  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

  3 month

Study Arms (2)

Chordate S101 Active

ACTIVE COMPARATOR

Active treatment With Device Chordate S101

Device: Chordate S101

Chordate S101 Placebo

PLACEBO COMPARATOR

Placebo treatment With Device Chordate S101

Device: Chordate S101 Placebo

Interventions

Chordate S101 DEVICE

Active treatment: The controller creates air-mediated kinetic oscillations with regulated pressure and frequency during a preset treatment time

Chordate S101 Active

Chordate S101 Placebo DEVICE

Placebo treatment: Placebo treatment is similar to active treatment, but with no oscillations. It is difficult to discern any difference between active and placebo treatment.

Chordate S101 Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Having nasal congestion as major symptom, and a median nasal congestion score of at least 2 (scale 0-3)
• Male or female 18 - 65 years
• Judged by the Investigator as suitable for participation in the study without safety concerns based on medical history and physical examination.
• Willing and able to provide written informed consent prior to participation in the clinical investigation
• Willing and able to comply with all study related procedures

You may not qualify if:

• Patients with Allergic rhinitis, demonstrated by either positive skin prick test, Phadiatop or RAST during the last year.
• 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
• History of frequent nose bleeds or a condition that increases the risk of excessive bleeding
• Pronounced anterior septal deviation or other significant nasal pathology at endoscopic examination
• Current malignancy of any kind
• Known allergy to polyvinylchloride or medicinal liquid paraffin
• 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.
• 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.
• Previous treated with radiation on the face, head or neck regions
• Received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer

Sponsors & Collaborators

• Chordate Medical: lead

Study Sites (13)

Charles University Faculty of Medicine in Hradec Králové

Hradec Králové, Czechia

Location

Hospital Pardubice

Pardubice, Czechia

Location

Charles University Motol University Hospital

Prague, Czechia

Location

Helsinki University Hospital

Helsinki, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Aristotle University

Thessaloniki, Greece

Location

Azienda Ospedaliera di Padova

Padua, Italy

Location

Fondazione Policlinico A Gemelli

Rome, Italy

Location

Academisch Medisch Centrum Amsterdam

Amsterdam, Netherlands

Location

University Hospital Birmingham

Birmingham, United Kingdom

Location

James Paget University Hospital

Great Yarmouth, United Kingdom

Location

Guys Hospital, Greate Maze Pond

London, United Kingdom

Location

MeSH Terms

Conditions

Nasal Obstruction; Common Cold

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 16, 2018
• Study Start: May 7, 2018
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: September 22, 2023

Record last verified: 2022-07

Locations

GR (1); NL (1); IT (2); CZ (3); FI (3); GB (3)