Biologic treatment for adults with ABPA and severe asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational cohort enrolling adults diagnosed with allergic bronchopulmonary aspergillosis (ABPA) according to the 2024 ISHAM criteria who also have severe bronchial asthma. Participants must be 18 or older, have had an acute asthma exacerbation within the past year, and have a blood eosinophil count of at least 150 cells/μL, and they will receive biologic agents as part of routine clinical care. Investigators will follow patients to record outcomes including exacerbation frequency, lung function, corticosteroid use, eosinophil counts, and adverse events. Because treatment is determined by clinicians rather than randomized assignment, the study describes real-world effectiveness and safety rather than providing randomized comparative evidence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Meet the diagnostic criteria of allergic bronchopulmonary aspergillosis, according to the ISHAM guidelines for the diagnosis and treatment of allergic bronchopulmonary aspergillosis (2024 revision).
2. The underlying disease was bronchial asthma, and it was severe bronchial asthma.
3. Have had an acute asthma attack in the past year. Acute exacerbation of asthma is defined as the sudden onset of wheezing, shortness of breath, cough, chest tightness and other symptoms beyond the definition of uncontrolled asthma, or the aggravation of the original symptoms, and is characterized by decreased expiratory flow, often induced by exposure to allergens, irritants or respiratory tract infection.
4. Blood eosinophil count ≥150 cells /μL.
5. Age ≥ 18 years old.

Exclusion Criteria:

1. The underlying diseases were chronic obstructive pulmonary disease and bronchiectasis;
2. Known allergic history to biological agents;
3. Human immunodeficiency virus infection, active pulmonary tuberculosis or pulmonary malignant tumor;
4. Complicated with other diseases requiring long-term systemic use of glucocorticoids or immunosuppressants (such as autoimmune diseases);
5. Pregnant or lactating women;
6. Currently participating in other interventional clinical research;
7. Any other conditions considered by the investigator to preclude participation in the study (e.g., nonadherence, predicted survival \<1 year, or severe mental illness that prevented cooperation).

Where it's running

• Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Qian Qi, Dr.
• Email: qiqianqlh@163.com
• Phone: +86 13706380314

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ML-based ABPA recurrence predictor in adults with ABPA

  A machine-learning model is being tested to see if it can predict the chance of an ABPA flare within a year in adults with ABPA during a stable phase.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07714863

• Fungal status and prognosis in ABPA: looking at who improves based on fungal tests

  This study checks if ABPA patients with positive or negative fungal tests in sputum or BALF have different outcomes over a year.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07690345

• Bronchoscopic airway clearance with amphotericin B spraying for ABPA

  This study will try bronchoscopic airway clearance plus amphotericin B spraying to see if it helps adults with allergic bronchopulmonary aspergillosis (ABPA) who have mucus plugs.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07362667

• Benralizumab treatment for adults with ABPA and severe asthma

  This will test whether benralizumab helps adults (18–75) who have severe asthma with allergic bronchopulmonary aspergillosis (ABPA).

  Recruiting at 2 sites Qianfoshan Hospital · Jinan, Shandong and 1 other locations · NCT07530770

• Stent-assisted Coil Embolization for Acute Ruptured Intracranial Aneurysms

  This study tests whether stent-assisted coil embolization for ruptured intracranial aneurysms can be safely used in the acute period and help prevent rebleeding.

  Recruiting Tang-Du Hospital · Xi'an, Shaanxi · NCT07683377

• Can a multi-omics and AI model predict ABPA relapse within 1 year in adults?

  This study tests a machine learning model that uses multi-omics and clinical data to predict the 1-year relapse risk for adults with ABPA who are in a stable state.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07611838

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.