Asthma: Phenotyping Exacerbations 3
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assessment of evidence of infection: Throat swab/nasal lavage for viral PCR.
研究概览
简要总结
Exacerbations of asthma (asthma attacks) are very common in the UK. They are frightening for patients, expensive for the health service, and occasionally lead to avoidable deaths.
Despite the obvious importance of asthma attacks, they remain poorly understood. Although some of the triggers for attacks are known, the resultant characteristics of attacks are not. Recent research has shown different inflammation profiles associated with asthma attacks; however, this is not well understood, and all asthma attacks are treated the same. Increased knowledge about the nature of asthma attacks may better define these attacks and help develop more targeted treatment options.
This study aims to describe the characteristics of patients admitted with asthma attacks. The recovery and response to standard treatment for asthma attacks following discharge from the hospital will also be described.
This is achieved by studying the characteristics of asthma attacks in patients hospitalized with acute asthma. Participants will be asked to attend two follow-up visits during which their response to treatment will be described.
The study is planned to last for 2.5 years, with a recruitment period of 18 months, and will include 100 participants with acute asthma.
详细描述
Asthma is a common condition affecting 9.8 million people in the United Kingdom1. Asthma attacks cause nearly 1500 deaths per year in the UK2 and account for over 90,000 hospital admissions and 1800 intensive care admissions costing at least 1 billion pounds a year3.
Non-asthma conditions such as Vocal Cord Dysfunction4 and Dysfunctional Breathing Pattern5 can mimic severe asthma and lead to hospital admission and inappropriate asthma treatment with potentially harmful high dose corticosteroids. However, the proportion of patients admitted with these asthma mimics is unclear.
The use of biomarkers to guide treatment in stable asthma is now commonplace, but this prospect has not been fully explored in acute asthma attacks. Determining the type of inflammation underlying an attack can, however be tricky because many patients receive oral corticosteroid prior to, or soon after admission, which promptly and markedly affects the most accessible type 2 asthma (T2) biomarkers7, the blood eosinophil count. Measurement of another T2 biomarker, fractional exhaled nitric oxide (FENO), during an attack may prove a useful measure of ongoing T2 airway inflammation, but this strategy requires assessment.
Airway obstruction in asthma attacks is assessed and confirmed by measuring peak expiratory flow and/or forced expiratory volumes. These measures are effort-dependent and can, therefore, be unreliable and misleading if improperly performed. We aim to evaluate the potential feasibility and utility of alternative diagnostic methods of assessing airway obstruction and measuring T2 biomarkers to see if these allow the distinction between actual asthma attacks and asthma attack mimics and also if they can distinguish different types of asthma attacks.
The pattern of recovery following asthma attacks is also not fully understood. Studies have reported varying recovery times8 and inconsistencies in the response of airway obstruction9 and T2 biomarkers10 to corticosteroid treatment in acute asthma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The ability to give fully informed consent
- •Male or female aged ≥ 18 years of age.
- •Admission with a suspected acute asthma attack.
- •Able (in the investigator's opinion) and willing to comply with clinical investigation requirements.
排除标准
- •Other clinically significant respiratory diseases including predominant Chronic Obstructive Pulmonary Disease (COPD) and bronchiectasis.
- •Any other clinically significant medical disease or uncontrolled concomitant disease that is likely, in the investigator's opinion, to impact the ability to participate in the study or the study results.
- •Pregnant women, lactating women or women who are planning to become pregnant.
- •Investigator determined apparent other cause for admission.
- •Acute COVID infection.
- •Non-English-speaking participants who are unable to comprehend the reasons for the study due to limitations in understanding the English language
结局指标
主要结局
Assessment of evidence of infection: Throat swab/nasal lavage for viral PCR.
时间窗: baseline
Assessment of evidence of infection: Throat swab/nasal lavage for viral PCR.
Assessment of airway obstruction at attack and recovery visits using spirometry.
时间窗: 14 days
Assessment of airway obstruction
Assessment of airway obstruction at attack and recovery visits using Forced Oscillation Technique (FOT).
时间窗: 14 days
Assessment of airway obstruction
Assessment of cytokine levels in nasal lining fluid at attack and recovery visits
时间窗: 14 days
Nasal absorption will be used to collect mucosal lining fluid from the respiratory tract for cytokines profiling at baseline (attack) and at second visits.
Assessment of adherence to medications (MARS, prescription records, inhaler technique) for the assessment of behavioural attack traits.
时间窗: baseline
Assessment of behavioural attack traits.
Assessment of airway obstruction at attack using physician recorded expiratory wheeze
时间窗: baseline
Assessment of airway obstruction
Assessment of airway inflammation at attack and recovery visits using sputum inflammatory cell count.
时间窗: 14 days
Assessment of airway inflammation
The assessment of the incidence of Gastroesophageal Reflux Disease.
时间窗: baseline
The assessment of the incidence of Gastroesophageal Reflux Disease using the GERDQ questionnaire.
The assessment of the incidence of anxiety and depression
时间窗: baseline
The assessment of the incidence of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS).
The measurement of vitamin D levels in the blood on admission to the hospital
时间窗: baseline
vitamin D levels in the blood on admission to the hospital
A specific asthma history (polypharmacy, previous asthma attacks, triggers, Personalised Asthma Action Plan) for the assessment of risk factor for attack.
时间窗: baseline
Assessment of risk factor for attack
Assessment of symptom burden at attack and recovery visits using the Acute AQLQ questionnaire
时间窗: 28 days
Assessment of symptom burden
Assessment of airway obstruction at attack and recovery visits using peak expiratory flow rate (PEFR).
时间窗: 14 days
Assessment of airway obstruction
Assessment of airway inflammation at attack and recovery visits using blood eosinophil count.
时间窗: 14 days
Assessment of airway inflammation
Assessment of the incidence of upper airway symptoms.
时间窗: baseline
The incidence of upper airway symptoms will be assessed using the Sino-nasal Outcome Test (SNOT).
The assessment of the incidence of vocal cord dysfunction
时间窗: baseline
The assessment of the incidence of vocal cord dysfunction using the Pittsburgh Vocal Cord Dysfunction (VCD) Index.
The assessment of the incidence of dysfunctional breathing
时间窗: baseline
The assessment of the incidence of dysfunctional breathing using the Nijmegen dysfunctional questionnaire.
Assessment of evidence of infection: sputum for bacterial culture and sensitivity (MC&S).
时间窗: 14 days
Assessment of evidence of infection: sputum for bacterial culture and sensitivity (MC\&S).
Assessment of evidence of infection: CRP.
时间窗: 14 days
Assessment of evidence of infection: CRP.
Assessment of airway inflammation at attack and recovery visits using Fractional Exhaled Nitric Oxide (FeNO).
时间窗: 14 days
Assessment of airway inflammation
Assessment of Body Mass Index BMI.
时间窗: baseline
Assessment of Body Mass Index BMI.
次要结局
未报告次要终点