Interest of IgE Directed Against Recombinant Antigens of Aspergillus Fumigatus in the Diagnosis of Allergic Bronchopulmonary Aspergillosis (ABPA)

NCT07055230 | Completed

• 2 other identifiers: 2021/163/OBN° IDRCB : 2021-A01632-39
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Bronchopulmonary Aspergillosis (ABPA)

Keywords

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (5)

• 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

  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

Secondary Outcomes (5)

• 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

Study Arms (1)

IgE Evaluation Group against recombinant Aspergillus fumigatus antigens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Chronic Obstructive Pulmonary Disease (COPD) with diagnosis of Allergic Bronchopulmonary Aspergillosis (ABPA)

You may qualify if:

• Adult patient (aged 18 years and older) being treated at Rouen University Hospital for chronic obstructive pulmonary disease and suspected of having ABPA
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Rouen Hospital

Rouen, 76031, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood from a blood sample taken during treatment during a specialist Pulmonology consultation, or during hospitalization in the Pulmonology department

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guillaume GM MAHAY, Doctor

  University Rouen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 8, 2025
• Study Start: January 8, 2022
• Primary Completion: February 2, 2024
• Study Completion: August 2, 2024
• Last Updated: July 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)