Study of the Interest of IgE Directed Against Recombinant Antigens of Aspergillus Fumigatus in the Diagnosis of Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients With Chronic Obstructive Bronchopulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Dosage of IgE (rAsp f1) directed against recombinant antigens of Aspergillus fumigatus
研究概览
简要总结
Allergic Bronchopulmonary Aspergillosis is a rare pulmonary disease involving allergic mechanisms, which historically affects patients with asthma or cystic fibrosis only. It is a source of respiratory decompensation. Its diagnosis requires the detection of total IgE, Aspergillus fumigatus-specific IgE, a chest X-ray or CT scan, Aspergillus fumigatus IgG and blood eosinophil measurement. These diagnostic criteria have several limitations in clinical practice. Indeed, radiographic abnormalities can be labile, and normal chest imaging therefore does not exclude the diagnosis but must be repeated. Similarly, blood eosinophils vary over time and are lowered by corticosteroid therapy. Finally, Aspergillus fumigatus specific IgE, when positive, does not allow us to distinguish simple sensitization from a true allergy to Aspergillus fumigatus.
详细描述
The advent of molecular allergology, with the measurement of IgE directed against recombinant Aspergillus fumigatus antigens (rAsp f1, f2, f3, f4, f6), has opened up a way to refine the diagnosis of ABPA. Thus, rAsp f1 and rAsp f3 positivity showed good sensitivity for the diagnosis of ABPA in asthma and cystic fibrosis (96.7% and 93.3%, respectively), while rAsp f4 and rAsp f6 positivity showed good specificity (99.2% and 93.9%, respectively). In 2016, Agarwal et al. proposed to extend the diagnostic criteria of ABPA to patients with chronic obstructive pulmonary disease (COPD). COPD is a common pathology, and exacerbation of COPD, whose triggering factor is often unknown, is a common reason for hospitalization. ABPA, when suspected, should be sought and managed in order to prevent respiratory decompensation and improve control of the underlying pathology. This study aims to prospectively evaluate the value of the assay IgE directed against recombinant Aspergillus fumigatus antigens (rAsp f1, f2, f3, f4, f6) in the diagnosis of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Chronic Obstructive Pulmonary Disease (COPD).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Adult patient (aged 18 years and older) being treated at Rouen University Hospital for chronic obstructive pulmonary disease and suspected of having ABPA
- •Laboratory tests performed or prescribed prior to inclusion.
- •Chest CT scan performed prior to inclusion.
- •Pulmonary Function Test performed or prescribed prior to inclusion.
- •Individual affiliated with a social security scheme
- •Individual who has read and understood the information sheet and does not object to participating in the study
排除标准
- •Patients not affiliated with Social Security
- •Minors (< 18 years old)
- •Persons under court protection, adult guardianship, or curatorship.
- •Patients with another primary chronic pulmonary condition (asthma without COPD, cystic fibrosis, post-tuberculous fibrocavitary disease).
- •Patients with eosinophilic granulomatosis with polyangiitis.
- •Patients with chronic pulmonary aspergillosis.
- •Patients with invasive aspergillosis.
- •Patients with hyper-IgE syndrome
- •Patients with progressive parasitic disease.
- •Patients receiving Omalizumab, Benralizumab, Mepolizumab, or Dupilumab, or whose treatment has been discontinued for less than 5.5 years.
- •Patients receiving long-term oral corticosteroid therapy, or whose long-term treatment has been discontinued for less than 28 days. • Patients on long-term antifungal treatment, or whose long-term treatment was stopped less than 28 days ago.
结局指标
主要结局
Dosage of IgE (rAsp f1) directed against recombinant antigens of Aspergillus fumigatus
时间窗: day 1
To evaluate the value of assaying IgE directed against recombinant Aspergillus fumigatus antigens in the diagnosis of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Chronic Obstructive Pulmonary Disease (COPD) by positivity (≥0.1 kUa/L) of IgE directed against recombinant Aspergillus fumigatus antigens (rAsp f1)
Dosage of IgE ( rAsp f2) directed against recombinant antigens of Aspergillus fumigatus
时间窗: day 1
To evaluate the value of assaying IgE directed against recombinant Aspergillus fumigatus antigens in the diagnosis of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Chronic Obstructive Pulmonary Disease (COPD) by positivity (≥0.1 kUa/L) of IgE directed against recombinant Aspergillus fumigatus antigens (rAsp f2)
Dosage of IgE (rAsp f3) directed against recombinant antigens of Aspergillus fumigatus
时间窗: day 1
To evaluate the value of assaying IgE directed against recombinant Aspergillus fumigatus antigens in the diagnosis of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Chronic Obstructive Pulmonary Disease (COPD) by positivity (≥0.1 kUa/L) of IgE directed against recombinant Aspergillus fumigatus antigens (rAsp f3)
Dosage of IgE (rAsp f4) directed against recombinant antigens of Aspergillus fumigatus
时间窗: day 1
To evaluate the value of assaying IgE directed against recombinant Aspergillus fumigatus antigens in the diagnosis of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Chronic Obstructive Pulmonary Disease (COPD) by positivity (≥0.1 kUa/L) of IgE directed against recombinant Aspergillus fumigatus antigens (rAsp f4)
Dosage of IgE (rAsp f6) directed against recombinant antigens of Aspergillus fumigatus
时间窗: day 1
To evaluate the value of assaying IgE directed against recombinant Aspergillus fumigatus antigens in the diagnosis of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Chronic Obstructive Pulmonary Disease (COPD) by positivity (≥0.1 kUa/L) of IgE directed against recombinant Aspergillus fumigatus antigens (rAsp f6)
次要结局
- Establish the threshold of positivity of IgE directed against recombinant antigens of Aspergillus fumigatus (rAsp f1) for the diagnosis of ABPA(day 1)
- Establish the threshold of positivity of IgE directed against recombinant antigens of Aspergillus fumigatus (rAsp f2) for the diagnosis of ABPA(day 1)
- Establish the threshold of positivity of IgE directed against recombinant antigens of Aspergillus fumigatus (rAsp f3) for the diagnosis of ABPA(day 1)
- Establish the threshold of positivity of IgE directed against recombinant antigens of Aspergillus fumigatus (rAsp f4) for the diagnosis of ABPA(day 1)
- Establish the threshold of positivity of IgE directed against recombinant antigens of Aspergillus fumigatus (rAsp f6) for the diagnosis of ABPA(day 1)