Non-allergic Rhinitis.NCT02136043
Kinetic Oscillation Stimulation (KOS) of Nasal Mucosa in Non-allergic Rhinitis: Investigation of Treatment Procedure
A study testing PBASE system 1.1 (active treatment) in people with Non-allergic Rhinitis., run by Halmstad County Hospital at 1 site in Sweden.
Trial summary
The purpose of the study is to evaluate how treatment with Kinetic Oscillation Stimulation (KOS) in the nasal cavity in patients with non-allergic rhinitis can be optimized to minimize any patient reported discomfort during treatment procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-allergic Rhinitis.
- What is being tested?
- PBASE system 1.1 (active treatment)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSweden
- Study dates
- May 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 procedure
Who cannot join
- Patients with Allergic rhinitis, demonstrated by either positive skin prick test, phadiatop or RAST(radioallergosorbent test)
- 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
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- 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 first visit at ENT(Ear, Nose and Throat) - clinic until treatment day (second visit)
- Female patients: unwilling to use adequate contraceptive between first and last visit
- Received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study (With Active Treatment in Both Treatment Groups) to Evaluate How a New Vibration Treatment in the Nose in Patients With Non-allergic Rhinitis Can be Done as Convenient as Possible to the Patient
The purpose of the study is to evaluate how treatment with Kinetic Oscillation Stimulation (KOS) in the nasal cavity in patients with non-allergic rhinitis can be optimized to minimize any patient reported discomfort during treatment procedure.
- Conditions
- Non-allergic Rhinitis.
- Being tested
- PBASE system 1.1 (active treatment)
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBASE system 1.1 (active treatment)Device
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Insertion of catheter into nasal cavity carried out by patient. Fixation of catheter during treatment with patient´s hand. Receives: Device: PBASE system 1.1 (active treatment) |
| Group 2 | Experimental | Insertion of catheter into nasal cavity carried out by health professional. Fixation of catheter during treatment with helmet. Receives: Device: PBASE system 1.1 (active treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score on the Visual Analogue Scale
To evaluate whether patient´s self-administration of catheter into nasal cavity is associated with a different degree of patient-reported pain on Visual Analogue Scales (VAS) compared to when administered by a health professional.
Measured: Five seconds after placement of catheter in nasal cavity
Secondary outcomes (1)
Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire
To evaluate if treatment effect (assessed 15 minutes before treatment and 14 days after treatment) by SNOT-22 is different between treatment groups.
Measured: Baseline, day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-allergic Rhinitis.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halmstad County Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Finn Jorgensen, Halmstad County Hospital
- Investigators
- Finn Jorgensen, M.D., Ph.D., Principal investigator, Halmstad County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136043
- Sponsor's protocol ID
- AHC14.
- Status last verified
- May 2015
- First submitted
- 5 May 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study (With Active Treatment in Both Treatment Groups) to Evaluate How a New Vibration Treatment in the Nose in Patients With Non-allergic Rhinitis Can be Done as Convenient as Possible to the Patient
- ClinicalTrials.gov ID
- NCT02136043
- Acronym / sponsor ID
- AHC14.
- Conditions
- Non-allergic Rhinitis.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Halmstad County HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate how treatment with Kinetic Oscillation Stimulation (KOS) in the nasal cavity in patients with non-allergic rhinitis can be optimized to minimize any patient reported discomfort during treatment procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: PBASE system 1.1 (active treatment)Insertion of catheter into nasal cavity carried out by patient. Fixation of catheter during treatment with patient´s hand. |
| Group 2 | Experimental | Device: PBASE system 1.1 (active treatment)Insertion of catheter into nasal cavity carried out by health professional. Fixation of catheter during treatment with helmet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- Patients with Allergic rhinitis, demonstrated by either positive skin prick test, phadiatop or RAST(radioallergosorbent test)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBASE system 1.1 (active treatment) | Device | Group 1, Group 2 |
Primary outcome
Pain score on the Visual Analogue Scale
Time frame: Five seconds after placement of catheter in nasal cavity
To evaluate whether patient´s self-administration of catheter into nasal cavity is associated with a different degree of patient-reported pain on Visual Analogue Scales (VAS) compared to when administered by a health professional.
1 secondary outcome
Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire
Time frame: Baseline, day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Finn Jorgensen, M.D., Ph.D. principal investigator
Halmstad County Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBASE system 1.1 (active treatment) in people with Non-allergic Rhinitis., run by Halmstad County Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score on the Visual Analogue Scale (time frame: Five seconds after placement of catheter in nasal cavity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.