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

NCT ID: NCT03399721

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 279 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-07
• Study Completion Date: 2022-09-30

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.

Conditions

Nasal Congestion; Non-allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Chordate S101 Active

Active treatment With Device Chordate S101

Group Type: ACTIVE_COMPARATOR

Chordate S101

Intervention Type: DEVICE

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

Chordate S101 Placebo

Placebo treatment With Device Chordate S101

Group Type: PLACEBO_COMPARATOR

Chordate S101 Placebo

Intervention Type: 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.

Interventions

Chordate S101

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

Intervention Type: DEVICE

Chordate S101 Placebo

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chordate Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Charles University Faculty of Medicine in Hradec Králové

Hradec Králové, , Czechia

Hospital Pardubice

Pardubice, , Czechia

Charles University Motol University Hospital

Prague, , Czechia

Helsinki University Hospital

Helsinki, , Finland

Kuopio University Hospital

Kuopio, , Finland

Tampere University Hospital

Tampere, , Finland

Aristotle University

Thessaloniki, , Greece

Azienda Ospedaliera di Padova

Padua, , Italy

Fondazione Policlinico A Gemelli

Rome, , Italy

Academisch Medisch Centrum Amsterdam

Amsterdam, , Netherlands

University Hospital Birmingham

Birmingham, , United Kingdom

James Paget University Hospital

Great Yarmouth, , United Kingdom

Guys Hospital, Greate Maze Pond

London, , United Kingdom

Countries

Czechia; Finland; Greece; Italy; Netherlands; United Kingdom

Other Identifiers

PR008

Identifier Type: -

Identifier Source: org_study_id