Clinical trial NCT03399721: Investigation of Kinetic Oscillation Stimulation by the Chordate System S101 in the Treatment of Non Allergic Rhinitis
Official title: A Clinical Investigation of Kinetic Oscillation Stimulation by the Chordate System S101 in the Treatment of Non Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Congestion
Non-allergic Rhinitis
Lead sponsor: Chordate Medical
Sponsor class: INDUSTRY
First posted: 2018-01-16
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nasal congestion
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hradec Králové
country: Czechia
facility: Charles University Faculty of Medicine in Hradec Králové
city: Pardubice
country: Czechia
facility: Hospital Pardubice
city: Prag
country: Czechia
facility: Charles University Motol University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Thessaloniki
country: Greece
facility: Aristotle University
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Rome
country: Italy
facility: Fondazione Policlinico A Gemelli
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum Amsterdam
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospital
city: London
country: United Kingdom
facility: Guys Hospital, Greate Maze Pond
Study officials:
References: