Bronchial and nasal and hyperreactivity in chronic (non-) allergic rhinitis

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 36

Inclusion Criteria

1. Inclusion criteria for all groups
Adults 18-70 years of age
2. Inclusion criteria per group
2.1 Chronic allergic rhinitis
- Symptoms of rhinitis: rhinorrhoea/ nasal blockage/ sneezing/ itchy nose for
at lease 1 hour daily for a minimum of 12 weeks per year.
- No signs of chronic rhinosinusitis (CRS) on nasal endoscopy (i.e. nasal
polyps, mucopurulent discharge primarily from the middle meatus, oedema/mucosal
obstruction primarily in the middle meatus) or computerized tomography scan
(i.e. mucosal changes in the ostiomeatal complex and/or sinuses).
- Positive for inhalational allergens test (skin-prick test, Phadiatop) with
clinically relevant sensitization in the last two years.
2.2 Chronic non-allergic rhinitis
- Symptoms of rhinitis: rhinorrhoea/ nasal blockage/ sneezing/ itchy nose for
at lease 1 hour daily for a minimum of 12 weeks per year.
- No signs of CRS on nasal endoscopy (i.e. nasal polyps, mucopurulent
discharge primarily from the middle meatus, oedema/mucosal obstruction
primarily in the middle meatus) or computerized tomography scan (i.e. mucosal
changes in the ostiomeatal complex and/or sinuses).
- Negative allergy test (skin-prick test, Phadiatop) in the last two years.
2.3 Controls
- No symptoms of rhinitis/rhinosinusitis like rhinorrhorea, nasal blockage,
itch, sneezing, facial pain, post nasal drip and loss of smell;
- No middle ear pathology;
- No asthma.
- Normal lung function (FEV1 >80% of predicted and FEV1/FVC ratio >0.75).
- Negative allergy test (skin-prick test).
- FeNO < 25 ppb.
- PC20 to histamine > 8 mg/ml

Exclusion Criteria

1) Acute upper or lower respiratory tract infection within 3 weeks before the
inclusion visit;
2) Chronic rhinosinusitis;
3) Systemic diseases affecting the nose (e.g., Wegener*s, granulomatosis,
sarcoid, primary ciliary dyskinesia, cystic fibrosis);
4) Inverted papilloma or malignant tumours of the sinonasal region;
5) Nasal/sinus surgery in the last 3 months;
6) Skin prick test or serum IgE measurement older than 2 years;
7) The presence of nasal mucosal erosion, nasal ulceration, or nasal septal
perforation;
8) A known history of alcohol or drug abuse within the last 2 years;
9) Recreational drug use in the past 72 hours;
10) Existence of any surgical or medical condition or physical or laboratory
findings, which in the opinion of the investigator, might significantly affect
the patient*s ability to complete this trial; or their safety in this trial;
11) Smoking (including participants who stopped smoking <6 months pre-testing
or participants who stopped smoking >6 months ago but smoked more than 5
packyears);
12) Exposed to passive smoking in the past 72 hours;
13) BMI > 30;
14) Topical nasal decongestant abuse;
15) Severe septal deviation, nasal valve dysfunction;
16) Pregnancy and nursing;
17) Medication affecting nasal function (e.g., β-blockers);
18) Subjects unable to stop using medication presented in Table 3 within the
corresponding timeframes;
19) Subjects unable to withdraw the use of medication presented in Attachment 1
with corresponding time periods before HBPT;
20) FEV1 < 60% predicted or 1.5 L;
21) Inability to perform acceptable and repeatable spirometry manoeuvres
throughout the test procedure;
22) Myocardial infarction or stroke in last 3 months;
23) Uncontrolled hypertension (BP systolic > 200 mmHg, diastolic > 100 mmHg);
24) Known aortic aneurysm;
25) Recent eye surgery or intracranial pressure elevation risk;
26) Inability to perform any of the testing manoeuvres, such as inhaling the
challenge agent consistently;
27) Use of cholinesterase inhibitor medication (e.g. for myasthenia gravis):
neostigmine, pyridostigmine
28) A positive COVID-19 self-test (within maximum of 48 hours prior to
bronchial provocation).
29) Any other physical or psychological factors precluding subjects of
participation in this protocol (either safety, compliance-wise) or as deemed by
the investigator.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The prevalence of NHR and BHR and the relationship between them in patients<br /><br>with chronic allergic and non-allergic rhinitis. Comparison with prevalence of<br /><br>NHR and BHR in the control group. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• The difference in the prevalence of NHR and BHR in patients with chronic<br /><br>allergic and non-allergic rhinitis and controls.<br /><br>• CDA reactivity in patients with chronic allergic and non-allergic rhinitis<br /><br>and controls.<br /><br>• Histamine Challange Test reactivity in patients with chronic allergic and<br /><br>non-allergic rhinitis and controls.</p><br>