Biologic treatment for adults with ABPA and severe asthma
A Prospective, Multicenter, Observational Cohort Study on the Efficacy and Safety of Biological Agents in Patients With Allergic Bronchopulmonary Aspergillosis
This project will test whether biologic medicines help adults with ABPA who have severe asthma and elevated eosinophils.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT07362693 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18 years) with ABPA per ISHAM 2024 who have severe asthma, at least one acute exacerbation in the past year, and a blood eosinophil count ≥150 cells/μL, without COPD or bronchiectasis.
Not a fit: Patients with underlying COPD or bronchiectasis, children under 18, people with very low eosinophil counts, known allergies to biologic agents, or active untreated HIV are unlikely to be eligible or to receive benefit from this study.
Why it matters
Potential benefit: If successful, biologic therapy could reduce asthma exacerbations and steroid dependence and improve lung function and quality of life for patients with ABPA.
How similar studies have performed: Small studies and case series of biologics such as anti-IgE and anti-IL-5/IL-4 pathway drugs have shown promising results in ABPA, but large randomized trials are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jinan, Shandong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.