Allergic Bronchopulmonary Aspergillosis (ABPA)BPCONCT07055230
Interest of IgE Directed Against Recombinant Antigens of Aspergillus Fumigatus in the Diagnosis of Allergic Bronchopulmonary Aspergillosis (ABPA)
An observational study of Allergic Bronchopulmonary Aspergillosis (ABPA), run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Bronchopulmonary Aspergillosis (ABPA)
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2022to 2 Aug 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Chronic Obstructive Pulmonary Disease (COPD) with diagnosis of Allergic Bronchopulmonary Aspergillosis (ABPA)
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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).
- Keywords
- Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Aspergillosis, Allergic Bronchopulmonary, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IgE Evaluation Group against recombinant Aspergillus fumigatus antigens | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Research on sensitivity and specificity of rAsp f1 antigen for the diagnosis of ABPA
Measured: day 1
Establish the threshold of positivity of IgE directed against recombinant antigens of Aspergillus fumigatus (rAsp f2) for the diagnosis of ABPA
Research on sensitivity and specificity of rAsp f2 antigen for the diagnosis of ABPA
Measured: 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
Measured: 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
Measured: 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
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start8 Jan 2022
- Primary completion2 Feb 2024
- Study completion2 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Bronchopulmonary Aspergillosis (ABPA)Studies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume GM MAHAY, Doctor, Principal investigator, University Rouen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055230
- Sponsor's protocol ID
- 2021/163/OB
- Other IDs
- N° IDRCB : 2021-A01632-39
- Acronym
- BPCO
- Status last verified
- May 2025
- First submitted
- 24 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07055230
- Acronym / sponsor ID
- BPCO / 2021/163/OB
- Keywords
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 8 Jan 2022 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IgE Evaluation Group against recombinant Aspergillus fumigatus antigens | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Chronic Obstructive Pulmonary Disease (COPD) with diagnosis of Allergic Bronchopulmonary Aspergillosis (ABPA)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dosage of IgE (rAsp f1) directed against recombinant antigens of Aspergillus fumigatus
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
5 secondary outcomes
Establish the threshold of positivity of IgE directed against recombinant antigens of Aspergillus fumigatus (rAsp f1) for the diagnosis of ABPA
Time frame: day 1
Establish the threshold of positivity of IgE directed against recombinant antigens of Aspergillus fumigatus (rAsp f2) for the diagnosis of ABPA
Time frame: day 1
Establish the threshold of positivity of IgE directed against recombinant antigens of Aspergillus fumigatus (rAsp f3) for the diagnosis of ABPA
Time frame: day 1
Establish the threshold of positivity of IgE directed against recombinant antigens of Aspergillus fumigatus (rAsp f4) for the diagnosis of ABPA
Time frame: day 1
Establish the threshold of positivity of IgE directed against recombinant antigens of Aspergillus fumigatus (rAsp f6) for the diagnosis of ABPA
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume GM MAHAY, Doctor principal investigator
University Rouen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Bronchopulmonary Aspergillosis (ABPA), run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of IgE (rAsp f1) directed against recombinant antigens of Aspergillus fumigatus (time frame: day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.