NCT02703467已完成不适用
Exhaled Hydrogen Sulphide as a Biomarker of Airways Disease in Asthma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Hydrogen Sulphide in Exhaled Breath
研究概览
简要总结
The purpose of this study will be to determine whether there is any role for measuring Hydrogen Sulphide (H2S) in the exhaled breath in terms of management of the patient with asthma.
The investigators will recruit patients with a range of severity of asthma and health volunteers. Levels of Hydrogen Sulphide will be measured in exhaled breath and blood. Also exhaled Nitric Oxide, Spirometry and asthma symptom scores will be measured at each study visit. Participants will attend either 2 or 4 separate visits.
The investigators will determine whether there is a relationship between exhaled Hydrogen Sulphide and asthma severity.
详细描述
Objectives:
- Perform a cross-sectional study in non-asthmatic subjects and asthmatic subjects of varying severities of the levels of Hydrogen Sulphide in exhaled breath in relation to the severity and control of asthma
- Compare the levels of exhaled Hydrogen Sulphide with exhaled Nitric Oxide.
We will recruit 30 health volunteers and 90 patients with a range of severity of asthma.
Particpants will attend for either 2 or 4 visits. At these visits the following measurements will be taken:
- Exhaled Hydrogen Sulphide
- Serum Hydrogen Sulphide
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
- 是
入选标准
- •All patients must be able to give informed consent. The definition of the severity of their asthma will be according to the GINA (Global Initiative for Asthma) guidelines dependent on the amount of therapy needed to control asthma. The investigators will also include at least 45 patients with severe asthma defined on the basis of: Uncontrolled asthma: three or more of the following features present in any week in the previous 4 weeks:
- •Daytime symptoms more than twice per week
- •Any limitation of activities
- •Nocturnal symptoms once or more per week
- •Need for reliever treatment more than twice per week
- •Pre bronchodilator FEV1 <80% predicted or personal best OR
- •Frequent severe exacerbations (≥2 per year) OR
- •Require prescription of daily or alternate day oral corticosteroids (OCS) to achieve asthma control despite the prescription of high dose inhaled corticosteroids (>1000mcg fluticasone propionate daily or equivalent) or maintenance oral corticosteroids plus a long acting beta agonist or one other controller medication (for example anti-cholinergics, leukotriene receptor antagonists or theophylline).
- •Diagnosis of asthma for the asthma cohort: Subjects must have asthma according to one or more of the following criteria documented in the last 12 months
- •improvement in FEV1 ≥ 12% and 200ml predicted after inhalation of 400 mcg salbutamol
- •airway hyper-responsiveness (PC20 <8mg/ml)
- •diurnal variation in PEF: amplitude % mean of twice daily PEF > 8%
- •decrease in pre bronchodilator FEV1 >12% and >200mls within 4 weeks after tapering treatment with one or more of the following drugs: inhaled corticosteroids, oral corticosteroids, long-acting beta-agonists, long-acting beta-agonists and short-acting beta-agonists.
- •PLUS a history of wheeze occurring spontaneously or on exertion
排除标准
- •Current smoker, or Ex-smoker with a >10 year pack history or having smoked within the past 6 months.
- •Significant alternative diagnoses that may mimic or complicate asthma, in particular dysfunctional breathing, panic attacks, and overt psychosocial problems (if these are thought to be the major problem rather than in addition to severe asthma)
- •Significant other primary pulmonary disorders in particular pulmonary embolism, pulmonary hypertension, interstitial lung disease and lung cancer
- •Subjects with emphysema and bronchiectasis should only be excluded if this is thought to be the major pulmonary disorder rather than in addition to severe asthma
- •Diagnosis or current investigation of occupational asthma
- •Any subjects currently participating, or having participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs.
结局指标
主要结局
Hydrogen Sulphide in Exhaled Breath
时间窗: At baseline visit
Level of hydrogen sulphide in exhaled breath measured as parts per billion
次要结局
- FVC (Forced Vital Capacity)(At 4 visits which occur during the study duration, up to 1 year)
- FEV1(At baseline visit)
- Exhaled Nitric Oxide(At 4 visits which occur during the study duration, up to 1 year)
- Blood Hydrogen Sulpide Level(At 4 visits which occur during the study duration, up to 1 year)
研究者
研究点 (1)
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