The clinical response will be measured in allergic and non-allergic rhinitis patients and healthy participants. This will be done by means of symptom scores: visual analogue score (VAS) and rhinitis symptome score (RSS) and by means of measuring…
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical outcomes (symptomscore and nasal flow):
Symptomscore
The patient will be asked 1 minute before and 1 minute after provocation to
assess the degree of their nasal symptoms by completing a 100 mm Visual
Analogue Scale (VAS) and a Rhinitis Symptom Score (RSS). An example of the 100
mm visual analogue scale is illustrated below:
No symptoms
Worst possible symptoms
The patients will also be asked to complete a rhinitis symptom score (RSS) for
the following symptoms: rhinorrhoea, nasal blockage, sneezing, itching in the
nose and burning in the nose.
Symptom score None (0) Mild (1) Severe (2)
Rhinorrhea
Blockage
Sneezing
Itching in nose
Burning in nose
Nasal Flow:
Peak Nasal Inspiratory Flow Rate (PNIF):
An "InCheck" peak nasal inspiratory flow meter is used to derive forced
inspiratory peak flow through the nose. Three maximal inspiratory efforts will
be made and the highest value recorded. PNIF will be measured one minute
before and minute after provocation.
Secondary outcome
not applicable
Background summary
Chronic rhinitis is a common disorder, that can have a great impact on quality
of life of patients.
The pathofysiology of chronic rhinitis is not completely understood. Especially
the role and definition of nasal hyperreactivity in the different types of
chronic rhinitis patients stays unclear. Hypotheses state that nasal
hyperreactivity could be a neurologic disorder or a disbalance of the sympathic
and parasympathic neurologic systems, a symptom with an inflammatoiry
background or even a hidden local allergy of the nasal mucosa.
For a long time nasal hyperreactivity was mainly correlated with non-allergic
rhinitis patients, but recent evidence shows that also allergic rhinitis
patients can have symptoms of nasal hyperreactivity, apart from their IgE
mediated allergy symptoms.
Study objective
The clinical response will be measured in allergic and non-allergic rhinitis
patients and healthy participants. This will be done by means of symptom
scores: visual analogue score (VAS) and rhinitis symptome score (RSS) and by
means of measuring nasal patency and flow: peak nasal inspiratory flowmetry
(PNIF).
Study design
Three groups of 30 participants, ie. 30 allergic rhinitis patients, 30
non-allergic rhinitis patients and 30 healthy controles will be included.
Participants will be recruted from previous studies of the ENT AMC Research
Departments (like the NAR study), but also from the population of (chronic)
rhinitis patients visiting the ENT outpatient clinic or the ENT research
department during the previous years and who all received a documented allergy
test (skin prick test).
To be included in our study allergy will be (again) investigated by means of a
skin prick test according to GA2LEN standards with the 18 most common
inhalation allergens. In non-allergic rhinitis patients and healthy controls
results of skin prick testing have to be completely negative apart from the
positive control. In allergic rhinitis patients apart from the positive control
at least one other positive result has to come up.
Chronic rhinitis patients have to have for at least 1 year symptoms of the
nose, ie at least one of the following symptoms: rhinorrhoea (runny nose),
nasal congestion (blocked nose), itchy nose, sneezing or burning/painful
sensation in the nose. These symptoms have to be at least troublesome for the
patient.
Patients have to stop local (or systemic) corticosteroids 4 weeks before their
visit, and antihistamines (spray or tablet) 3 days before their visit.
The visit will include a screening and allergy investigation (skin prick test).
(60 minutes) During this screening visit demographic features and symptoms of
rhinitis, medicale history and medication use -as applicable- will be
documented and an ENT and a short general physical examination will be
performed.
Than provocation with cold dry air will take place. (20 minutes) One minute
before provocation patients will fill in a Visual Analogue Scale (VAS) for 5
different nasal symptoms. (rhinorrhoea, nasal congestion, itchy nose, sneezing,
burning/pain) and a Rhinitis Symptom Score (RSS) for the same 5 symptoms. Also
a Peak Nasal Inspiratoiry Flow Measurement (PNIF) will be performed to assess
nasal patency.
After this screening part a provocation of 15 minutes breathing of cold dry air
of at least minus 10 degrees Celcius with a flow of 25 L/minute through the
nose with a nasal silicon mask will take place, as described by Braat etal in
1997. At one minute after ending 15 minutes provocation, patients will again
fill in the VAS scores and RSS scores and perform another Peak Nasal
Inspiratory Flow Measurement (PNIF).
After these measurements the visit will be ended.
Intervention
All groups will undergo a nasal provocation with dry cold air for 15 minutes.
Study burden and risks
Patients with rhinitis stop the use of their nasal medication within one month
before participation. Antihistamines will not be taken 48 hour before the
visit. There is a chance of a considerable increase of their rhinitis symptoms.
If abstinence from their medication is not possible, subjects cannot be
included in this study.
All participants visite the ENT- Research Department during two hours, in
which skinprick test, screening and nasal provocation will be performed.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Male or female between 18-68 years of age inclusive capable of giving written informed consent
Exclusion criteria
Use of nasal corticosteroids within 4 weeks before participation
Nasal conditions likely to effect the outcome of the study, i.e. nasal malformations
Use of intranasal medication to treat nasal symptoms
Nasal or sinussurgery in the previous three months
Use of antihistamines in the 48 hours before each visit
Recent upper airway infection
Serious or unstable co-morbidity
A diagnosis of asthma
Pregnant or lactating females
Past medical history of nasal polyposis
Smoking
Inability to follow the instructions or completing all studyprocedures
Design
Recruitment
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 | NL39904.018.12 |