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| ID | Type | Description | Link |
|---|---|---|---|
| N° IDRCB : 2021-A01632-39 | Other Identifier | ANSM |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgE Evaluation Group against recombinant Aspergillus fumigatus antigens |
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| Measure | Description | Time Frame |
|---|---|---|
| Dosage of IgE (rAsp f1) directed against recombinant antigens of Aspergillus fumigatus | 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) | day 1 |
| Dosage of IgE ( rAsp f2) directed against recombinant antigens of Aspergillus fumigatus | 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) | day 1 |
| Dosage of IgE (rAsp f3) directed against recombinant antigens of Aspergillus fumigatus | 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) | day 1 |
| Dosage of IgE (rAsp f4) directed against recombinant antigens of Aspergillus fumigatus | 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) | day 1 |
| Dosage of IgE (rAsp f6) directed against recombinant antigens of Aspergillus fumigatus |
| Measure | Description | Time Frame |
|---|---|---|
| Establish the threshold of positivity of IgE directed against recombinant antigens of Aspergillus fumigatus (rAsp f1) for the diagnosis of ABPA | Research on sensitivity and specificity of rAsp f1 antigen 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Chronic Obstructive Pulmonary Disease (COPD) with diagnosis of Allergic Bronchopulmonary Aspergillosis (ABPA)
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume GM MAHAY, Doctor | University Rouen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Rouen Hospital | Rouen | 76031 | France |
The data provided will be the property of the sponsor and will be used solely for its own research activities.
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whole blood from a blood sample taken during treatment during a specialist Pulmonology consultation, or during hospitalization in the Pulmonology department
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)
| day 1 |
Research on sensitivity and specificity of rAsp f2 antigen 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 | Research on sensitivity and specificity of rAsp f3 antigen 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 | Research on sensitivity and specificity of rAsp f4 antigen 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 | Research on sensitivity and specificity of rAsp f6 antigen for the diagnosis of ABPA | day 1 |
| ID | Term |
|---|---|
| D001229 | Aspergillosis, Allergic Bronchopulmonary |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D055732 | Pulmonary Aspergillosis |
| D001228 | Aspergillosis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008172 | Lung Diseases, Fungal |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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