Characteristics of the Eosinophilic Asthma Phenotype: an Observational Study in Patients From a Tertiary Care Center With Various Asthma Severities: The Quebec Heart and Lung Institute-Laval University Retrospective Asthma Database Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 918
- 试验地点
- 1
- 主要终点
- Asthma severity according to medication use
研究概览
简要总结
In asthma, the type and importance of the inflammatory response in the airways has allows identification of different phenotypes. Of these, one of the most common is eosinophilic asthma, based on induced sputum differential cell count. Patients with severe asthma and an eosinophilic asthma phenotype have different pathophysiological characteristics than those seen in patients with with mild asthma. However, few studies have compared patients with eosinophilic phenotype according to the severity of asthma. In addition, the stability of the phenotype based on the sputum results has been criticized.
This study aims to describe the characteristics of patients with eosinophilic asthma phenotype according to the severity of asthma and determine the stability of the phenotype.
详细描述
Characteristics of asthmatic subjects with sputum eosinophilia will be compared according to asthma severity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Aged 18 years and over
- •With a proven diagnosis of asthma as defined by one of the above criteria of current guidelines (36):
- •Forced expiratory volume in one second (FEV1) increase by at least 12% (and ≥200 ml) after administration of a bronchodilator
- •Current asthma symptoms and a methacholine provocative concentration inducing a 20% fall in FEV1 (PC20) <16 mg/ml
- •A respirologist's current diagnosis of asthma found in the patient's medical report
- •Non-smokers or smokers/ex-smokers defined as someone with a smoking history <10 pack-years
- •With sputum differential cell count result
- •Considered to receive optimal treatment for their disease (as per current guidelines except for patients included in exploratory objective
- •Stable asthma and asthma medication for at least 4 weeks before data analysis
- •Written informed consent obtained for inclusion in the database
排除标准
- •Any respiratory disease apart from asthma
- •Current or ex-smokers should not have a smoking history ≥10 pack-year before data analysis. Patients who administer nicotine in other forms (patches, chew tobacco, e-cigarette, etc.) will be excluded
- •Unstable asthma medication <4 weeks before data analysis
- •Asthma exacerbation (see definition below) <4 weeks before data analysis
- •Respiratory tract infection <4 weeks before data analysis
结局指标
主要结局
Asthma severity according to medication use
时间窗: Baseline
Prevalence of patients with 3% or more sputum eosinophils in mild, moderate and severe asthma
次要结局
- FEV1 percent predicted(Baseline)
- ACSS symptom sub-score(Baseline)
研究者
Louis-Philippe Boulet
MD, FRCPC, Respirologist
Laval University