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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
279
Active treatment: The controller creates air-mediated kinetic oscillations with regulated pressure and frequency during a preset treatment time
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.
Charles University Faculty of Medicine in Hradec Králové
Hradec Králové, Czechia
Hospital Pardubice
Pardubice, Czechia
Charles University Motol University Hospital
Prague, Czechia
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
Time frame: 3 month
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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
...and 3 more locations