Objectives are to evaluate the efficacy of the procedure in reducing disease specific symptoms such as nasal congestion, rhinorrhea, nasal itching and sneezing, but also to investigate the influence on quality of life, safety and tolerability.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Non Allergic Rhinitis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary performance endpoint is the responder rate based on the change in
the weekly median nasal congestion score (taken from TNSS) from baseline to the
3 month follow-up visit
Secondary outcome
Responder rates based on the change from baseline to the other follow-up visits
in the nasal congestion score (taken from TNSS)
* Change from baseline to each of the follow-up visits in weekly mean Total
Nasal Symptom Score (TNSS)
* Change from baseline to each of the follow-up visits in Total Nasal
Obstruction and Septoplasty Effectiveness (NOSE) Score
* Responder rates based on the change from baseline to each of the follow-up
visits in each of the individual symptoms scores in the Nasal Obstruction and
Septoplasty Effectiveness Scale (NOSE)
* Change from baseline to each of the follow-up visits in Peak Nasal
Inspiratory Flow (PNIF)
* Patient assessment of change in their disease status
* Patient satisfaction
* Change from baseline to each of the follow-up visits in functional disability
and health-related quality of life, according to the EQ-5D-5L questionnaire
* Use of rescue medication
Background summary
Nasal obstruction is a very common disorder which can be caused by both
anatomical and mucosal reasons. In the case of anatomical reasons septal
deviation and other skeletal defects are causative. Mucosal disorders are due
to a lot of underlying diseases of which allergic rhinitis, is the most common
(1). When allergic rhinitis and infections are ruled out as underlying diseases
the term non-allergic non-infectious rhinitis or simply non-allergic rhinitis
(NAR) is used to describe rhinitis of unknown origin. In epidemiologic studies
as much as 10-20 % of the population is found to fulfill these criteria*s of
non-allergic rhinitis, i.e.no causative reason is found to the complaints
although a thorough examination (2-3). Synonymously to NAR the term vaso-motor
rhinitis (VMR) was earlier used. The most prominent symptom in NAR is nasal
blockage but in some patients nasal hyper secretion is dominating. Histamine
related symptoms like itching and sneezing are not seen. However, effects on
quality of life can be very substantial (4-5). And treatment is mostly
difficult to make successful although local corticosteroids can give relief to
nasal blockage in NAR (6). Poor results in the treatment may be due to a
multiple related etiology of NAR like occupation, hormones, drugs. Due to a
lack of reliable immunological markers the role of the nerve system in the
nasal cavity is of interest. Mechanisms behind the disease is thus to some
extent obscure even if we know that there is some sort of imbalance in the
neural regulation of the mucosal lining of the nose. The balance between
sympathetic and parasympathetic control of the vessels and thereby an imbalance
of the degree of nasal blockage is the ground for the term of *vaso-motor
rhinitis*. Probably, interactions between the immune system and the nerve
system contribute to nasal diseases therefore the activity of the nerve system
is interesting in patients with NAR.
Study objective
Objectives are to evaluate the efficacy of the procedure in reducing disease
specific symptoms such as nasal congestion, rhinorrhea, nasal itching and
sneezing, but also to investigate the influence on quality of life, safety and
tolerability.
Study design
This is a double-blind, placebo-controlled, multi-center study in which
patients diagnosed with non-allergic rhinitis will receive intranasal
stimulation with the Chordate System at two occasions
Intervention
treatment with the Catheter A100 combined with the Chordate System S101).
Study burden and risks
Nature and extent of the burden and risks are described in the protocol on page
36 - 38 of the protocol
Norgegatan 2
Krista 164 32
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Norgegatan 2
Krista 164 32
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Listed location countries
Age
Inclusion criteria
Patients with persistent (>12w) symptoms of non-allergic 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.
2. Having nasal congestion as major symptom, and a median nasal congestion
score of at least 2 (scale 0-3)
3. Male or female 18 * 65 years
4. Judged by the Investigator as suitable for participation in the study
without safety concerns based on medical history and physical examination.
5. Willing and able to provide written informed consent prior to participation
in the clinical investigation
6. 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 during the last year.
2. Ongoing respiratory tract infection including nasal cavity at inclusion
3. Systemic steroid treatment less than 4 weeks before the inclusion in the
study
4. Patients with a history of nasal surgery like: septoplasty, cosmetic
surgery, conchal surgery or any other nasal surgery except closed reposition
for nasal fracture during last year
5. History of frequent nose bleeds or a condition that increases the risk of
excessive bleeding
6. Pronounced anterior septal deviation or other significant nasal pathology at
endoscopic examination
7. Current malignancy of any kind
8. Known allergy to polyvinylchloride or medicinal liquid paraffin
9. Any disease, condition (medical or surgical) or drug or alcohol abuse which,
in the opinion of the investigator, might compromise the study results, or
would place the patient at increased risk.
10. 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.
11. Previous treated with radiation on the face, head or neck regions
12. Female patients who are pregnant or become pregnant at any time from
inclusion of the study until end of the 8 week follow-up visit
13. Received study drug in a clinical trial for an investigational drug within
the previous 30 days, or 5 half-lives, whichever is longer
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64268.018.18 |