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

Primary Purpose

Nasal Congestion, Non-allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Chordate S101
Chordate S101 Placebo
Sponsored by
Chordate Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Congestion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charles University Faculty of Medicine in Hradec Králové
  • Hospital Pardubice
  • Charles University Motol University Hospital
  • Helsinki University Hospital
  • Kuopio University Hospital
  • Tampere University Hospital
  • Aristotle University
  • Azienda Ospedaliera di Padova
  • Fondazione Policlinico A Gemelli
  • Academisch Medisch Centrum Amsterdam
  • University Hospital Birmingham
  • James Paget University Hospital
  • Guys Hospital, Greate Maze Pond

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Chordate S101 Active

Chordate S101 Placebo

Arm Description

Active treatment With Device Chordate S101

Placebo treatment With Device Chordate S101

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 9, 2018
Last Updated
September 21, 2023
Sponsor
Chordate Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03399721
Brief Title
Investigation of Kinetic Oscillation Stimulation by the Chordate System S101 in the Treatment of Non Allergic Rhinitis
Acronym
KOSNAR
Official Title
A Clinical Investigation of Kinetic Oscillation Stimulation by the Chordate System S101 in the Treatment of Non Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 7, 2018 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chordate Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Congestion, Non-allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
279 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chordate S101 Active
Arm Type
Active Comparator
Arm Description
Active treatment With Device Chordate S101
Arm Title
Chordate S101 Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo treatment With Device Chordate S101
Intervention Type
Device
Intervention Name(s)
Chordate S101
Intervention Description
Active treatment: The controller creates air-mediated kinetic oscillations with regulated pressure and frequency during a preset treatment time
Intervention Type
Device
Intervention Name(s)
Chordate S101 Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nasal congestion
Description
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
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients with Allergic rhinitis, demonstrated by either positive skin prick test, Phadiatop or RAST during the last year. Ongoing respiratory tract infection including nasal cavity at inclusion Systemic steroid treatment less than 4 weeks before the inclusion in the study 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 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 Received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer
Facility Information:
Facility Name
Charles University Faculty of Medicine in Hradec Králové
City
Hradec Králové
Country
Czechia
Facility Name
Hospital Pardubice
City
Pardubice
Country
Czechia
Facility Name
Charles University Motol University Hospital
City
Prag
Country
Czechia
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Aristotle University
City
Thessaloniki
Country
Greece
Facility Name
Azienda Ospedaliera di Padova
City
Padova
Country
Italy
Facility Name
Fondazione Policlinico A Gemelli
City
Rome
Country
Italy
Facility Name
Academisch Medisch Centrum Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
University Hospital Birmingham
City
Birmingham
Country
United Kingdom
Facility Name
James Paget University Hospital
City
Great Yarmouth
Country
United Kingdom
Facility Name
Guys Hospital, Greate Maze Pond
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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