Interest of IgE Directed Against Recombinant Antigens of Aspergillus Fumigatus in the Diagnosis o… (NCT07055230) | Clinical Trial Compass
CompletedNot Applicable
Interest of IgE Directed Against Recombinant Antigens of Aspergillus Fumigatus in the Diagnosis of Allergic Bronchopulmonary Aspergillosis (ABPA)
France67 participantsStarted 2022-01-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dosage of IgE (rAsp f1) directed against recombinant antigens of Aspergillus fumigatus
Timeframe: day 1
2
Dosage of IgE ( rAsp f2) directed against recombinant antigens of Aspergillus fumigatus
Timeframe: day 1
3
Dosage of IgE (rAsp f3) directed against recombinant antigens of Aspergillus fumigatus
Timeframe: day 1
4
Dosage of IgE (rAsp f4) directed against recombinant antigens of Aspergillus fumigatus
Timeframe: day 1
5
Dosage of IgE (rAsp f6) directed against recombinant antigens of Aspergillus fumigatus