Back to resultsPBASE System Idiopathic Rhinitis Clinical Investigation
Primary Purpose
Idiopathic Rhinitis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
PBASE system 1.1 + CT100 (active treatment)
PBASE system 1.1 + CT100 (placebo treatment)
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PBASE system 1.1 + CT100 (active treatment)
PBASE system 1.1 + CT100 (placebo treatment)
Arm Description
Outcomes
Primary Outcome Measures
Change in total vasomotor rhinitis symptom score to visit 3
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01844336
Brief Title
PBASE System Idiopathic Rhinitis Clinical Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chordate Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PBASE system 1.1 + CT100 (active treatment)
Arm Type
Experimental
Arm Title
PBASE system 1.1 + CT100 (placebo treatment)
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
PBASE system 1.1 + CT100 (active treatment)
Intervention Type
Device
Intervention Name(s)
PBASE system 1.1 + CT100 (placebo treatment)
Primary Outcome Measure Information:
Title
Change in total vasomotor rhinitis symptom score to visit 3
Time Frame
From baseline to 28 days after treatment visit 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Falun
Country
Sweden
City
Gothenburg
Country
Sweden
City
Lund
Country
Sweden
City
Stockholm
Country
Sweden
City
Västerås
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
PBASE System Idiopathic Rhinitis Clinical Investigation
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