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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chordate S101 Active | Active Comparator | Active treatment With Device Chordate S101 |
|
| Chordate S101 Placebo | Placebo Comparator | Placebo treatment With Device Chordate S101 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chordate S101 | Device | Active treatment: The controller creates air-mediated kinetic oscillations with regulated pressure and frequency during a preset treatment time |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles University Faculty of Medicine in Hradec Králové | Hradec Králové | Czechia | ||||
| Hospital Pardubice |
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| Chordate S101 Placebo | 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. |
|
| 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 | Padova | 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 |
| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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