NL-OMON52412招募中不适用
Bronchial and nasal and hyperreactivity in chronic (non-) allergic rhinitis - BANA(H)NA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
排除标准
- •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.
研究者
相似试验
已完成
不适用
High Concentration Oxygen in BronchiectasisRespiratory - Other respiratory disorders / diseasesBronchiectasisACTRN12612000356864Janine Pilcher24
已完成
不适用
Prevalence of Nasal Hyperreactivity in Chronic Upper Airway InflammationChronic RhinitisHyperactivityChronic Rhinosinusitis (Diagnosis)Upper Respiratory DiseaseNCT03893227Universitaire Ziekenhuizen KU Leuven756
尚未招募
4 期
The use of the oral antibiotic, roxithromycin, prior to endoscopic surgery of the paranasal sinuses, to improve the surgical field and outcomesOther - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)Inflammatory and Immune System - Other inflammatory or immune system disordersChronic rhinosinusitisACTRN12611000485932Royal Victorian Eye and Ear Hospital58
已完成
2 期
Omalizumab for Chronic Allergic Bronchopulmonary Aspergillosis: a randomised, placebo-controlled crossover trialAllergic Bronchopulmonary AspergillosisRespiratory - Other respiratory disorders / diseasesInflammatory and Immune System - Other inflammatory or immune system disordersACTRN12613000278730Jo Douglass14
招募中
不适用
Development of Rhinitis, Ezcema and Asthma in allergic MarchKCT0007041Samsung Medical Center300