NCT02136043

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

May 5, 2014

Last Update Submit

May 25, 2015

Conditions

Non-allergic Rhinitis.

Outcome Measures

Primary Outcomes (1)

  • 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.

    Five seconds after placement of catheter in nasal cavity

Secondary Outcomes (1)

  • Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire

    Baseline, day 14

Other Outcomes (1)

  • Peak Nasal Inspiratory Flow (PNIF)

    Baseline, day 14

Study Arms (2)

Group 1

EXPERIMENTAL

Insertion of catheter into nasal cavity carried out by patient. Fixation of catheter during treatment with patient´s hand.

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.

Device: PBASE system 1.1 (active treatment)

Interventions

PBASE system 1.1 (active treatment)DEVICE
Group 1Group 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with Allergic rhinitis, demonstrated by either positive skin prick test, phadiatop or RAST(radioallergosorbent test)
  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ear, Nose and Throat Dept, Halmstad County Hospital

Halmstad, Sweden

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Finn Jorgensen, M.D., Ph.D.

    Halmstad County Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Finn Jorgensen, M.D., Ph.D.

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 12, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

SE(1)