Non Allergic Rhinitis continous sneezing Non Alleric Rhinitis running nose
Conditions
Interventions
treatment with the Catheter A100 combined with the Chordate System S101).
Sponsors
Chordate medical AB
Eligibility
Age
18 Years to 99 Years
Inclusion 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. 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary performance endpoint is the responder rate based on the change in the weekly median nasal congestion score (taken from TNSS) from baseline to the 3 month follow-up visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Responder rates based on the change from baseline to the other follow-up visits in the nasal congestion score (taken from TNSS) * Change from baseline to each of the follow-up visits in weekly mean Total Nasal Symptom Score (TNSS) * Change from baseline to each of the follow-up visits in Total Nasal Obstruction and Septoplasty Effectiveness (NOSE) Score * Responder rates based on the change from baseline to each of the follow-up visits in each of the individual symptoms scores in the Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE) * Change from baseline to each of the follow-up visits in Peak Nasal Inspiratory Flow (PNIF) * Patient assessment of change in their disease status * Patient satisfaction * Change from baseline to each of the follow-up visits in functional disability and health-related quality of life, according to the EQ-5D-5L questionnaire * Use of rescue medication | — |
Countries
Netherlands
Outcome results
None listed