Idiopathic Rhinitis Clinical Trial
| NCT number | NCT01844336 |
| Other study ID # | PR003 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | April 24, 2013 |
| Last updated | September 8, 2014 |
| Verified date | September 2014 |
| Source | Chordate Medical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Regional Ethical Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 208 |
| Est. completion date | |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Chordate Medical |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in total vasomotor rhinitis symptom score to visit 3 | From baseline to 28 days after treatment visit 1 | No |