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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52412
Enrollment
36
Registered
2020-07-31
Start date
2021-10-07
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blocked nose Chronic rhinitis running nose

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)