Nasal CongestionKOSNARNCT03399721
Investigation of Kinetic Oscillation Stimulation by the Chordate System S101 in the Treatment of Non Allergic Rhinitis
A study testing Chordate S101 in people with Nasal Congestion and Non-allergic Rhinitis, run by Chordate Medical at 13 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasal Congestion, Non-allergic Rhinitis
- What is being tested?
- Chordate S101
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 279 participants
- Where
- 13 sitesin 6 countries
- Study dates
- 7 May 2018to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
Czechia3 sites
Charles University Faculty of Medicine in Hradec Králové
Hradec Králové
Hospital Pardubice
Pardubice
Charles University Motol University Hospital
Prague
Finland3 sites
Helsinki University Hospital
Helsinki
Kuopio University Hospital
Kuopio
Tampere University Hospital
Tampere
United Kingdom3 sites
University Hospital Birmingham
Birmingham
James Paget University Hospital
Great Yarmouth
Guys Hospital, Greate Maze Pond
London
Italy2 sites
Azienda Ospedaliera di Padova
Padova
Fondazione Policlinico A Gemelli
Rome
About this study
Official title: A Clinical Investigation of Kinetic Oscillation Stimulation by the Chordate System S101 in the Treatment of Non Allergic Rhinitis
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.
Read the 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.
- Conditions
- Nasal Congestion, Non-allergic Rhinitis
- Being tested
- Chordate S101, Chordate S101 Placebo
- Medical subject headings
- Nasal Obstruction, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chordate S101Device
Active treatment: The controller creates air-mediated kinetic oscillations with regulated pressure and frequency during a preset treatment time
Chordate S101 PlaceboDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Chordate S101 Active | Active comparator | Active treatment With Device Chordate S101 Receives: Device: Chordate S101 |
| Chordate S101 Placebo | Placebo comparator | Placebo treatment With Device Chordate S101 Receives: Device: Chordate S101 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start7 May 2018
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal CongestionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chordate Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399721
- Sponsor's protocol ID
- PR008
- Acronym
- KOSNAR
- Status last verified
- Jul 2022
- First submitted
- 9 Jan 2018
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation of Kinetic Oscillation Stimulation by the Chordate System S101 in the Treatment of Non Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT03399721
- Acronym / sponsor ID
- KOSNAR / PR008
- Conditions
- Nasal Congestion, Non-allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Chordate MedicalIndustry (pharma, biotech, devices)
- Study start
- 7 May 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chordate S101 Active | Active comparator | Device: Chordate S101Active treatment With Device Chordate S101 |
| Chordate S101 Placebo | Placebo comparator | Device: Chordate S101 PlaceboPlacebo treatment With Device Chordate S101 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chordate S101Active treatment: The controller creates air-mediated kinetic oscillations with regulated pressure and frequency during a preset treatment time | Device | Chordate S101 Active |
| Chordate S101 PlaceboPlacebo treatment: Placebo treatment is similar to active treatment, but with no oscillations. It is difficult to discern any difference between active and placebo treatment. | Device | Chordate S101 Placebo |
Primary outcome
Nasal congestion
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chordate S101 in people with Nasal Congestion and Non-allergic Rhinitis, run by Chordate Medical at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Czechia, Finland, United Kingdom, Italy, Greece and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal congestion (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.