Clinical trial NCT01844336: PBASE System Idiopathic Rhinitis Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Rhinitis
Lead sponsor: Chordate Medical
Sponsor class: INDUSTRY
First posted: 2013-05-01
Enrollment: 208
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: The purpose of this study is to evaluate the performance of the PBASE system, in terms of the efficacy of treatment in patients with idiopathic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Patients with persistent (\>12w) symptoms of idiopathic 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
* Having nasal congestion as major symptom, and a nasal congestion score of at least 2 (scale 0-3)
* Male or female 18 - 65 years
* Judged by the Investigator as suitable for participation in the study without safety concerns based on medical history and physical examination.
* Willing and able to provide written informed consent prior to participation in the clinical investigation
* Willing and able to comply with all study related procedures

Exclusion Criteria:

* Patients with Allergic rhinitis, demonstrated by either positive skin prick test, phadiatop or RAST
* Ongoing respiratory tract infection including nasal cavity at inclusion (treatment visit 1)
* Systemic steroid treatment less than 4 weeks before the inclusion in the study
* Patients with a history of nasal surgery like: septoplasty, cosmetic surgery, conchal surgery or any other nasal surgery except closed reposition for nasal fracture
* History of frequent nose bleeds or a condition that increases the risk of excessive bleeding
* Pronounced anterior septal deviation or other significant nasal pathology at endoscopic examination
* Current malignancy of any kind
* Known allergy to polyvinylchloride or medicinal liquid paraffin
* Any disease, condition (medical or surgical) which, in the opinion of the investigator, might compromise the study results, or would place the subject at increased risk.
* 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.
* Previous treated with radiation on the face, head or neck regions
* Female patients who are pregnant or nursing, or become pregnant at any time from inclusion of the study until end of the 8 week follow-up visit
* Female patients: unwilling to use adequate contraceptive from the signing of the informed consent until end of the 8 week follow-up visit
* 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: Change in total vasomotor rhinitis symptom score to visit 3
timeFrame: From baseline to 28 days after treatment visit 1
Secondary outcomes:
Other outcomes:
Locations:
city: Falun
country: Sweden
city: Gothenburg
country: Sweden
city: Lund
country: Sweden
city: Stockholm
country: Sweden
city: Västerås
country: Sweden
Study officials:
References: