blocked nose Chronic rhinitis running nose
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
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 8 mg/ml
Exclusion criteria
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 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The prevalence of NHR and BHR and the relationship between them in patients with chronic allergic and non-allergic rhinitis. Comparison with prevalence of NHR and BHR in the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| • The difference in the prevalence of NHR and BHR in patients with chronic allergic and non-allergic rhinitis and controls. • CDA reactivity in patients with chronic allergic and non-allergic rhinitis and controls. • Histamine Challange Test reactivity in patients with chronic allergic and non-allergic rhinitis and controls. | — |
Countries
Netherlands