Status:
RECRUITING
A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA
Lead Sponsor:
Qianfoshan Hospital
Conditions:
ABPA
Biologics
Eligibility:
All Genders
18+ years
Brief Summary
To evaluate the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis.
Eligibility Criteria
Inclusion Criteria:
- Meet the diagnostic criteria of allergic bronchopulmonary aspergillosis, according to the ISHAM guidelines for the diagnosis and treatment of allergic bronchopulmonary aspergillosis (2024 revision).
- The underlying disease was bronchial asthma, and it was severe bronchial asthma.
- 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.
- Blood eosinophil count ≥150 cells /μL.
- Age ≥ 18 years old.
Exclusion Criteria:
- The underlying diseases were chronic obstructive pulmonary disease and bronchiectasis;
- Known allergic history to biological agents;
- Human immunodeficiency virus infection, active pulmonary tuberculosis or pulmonary malignant tumor;
- Complicated with other diseases requiring long-term systemic use of glucocorticoids or immunosuppressants (such as autoimmune diseases);
- Pregnant or lactating women;
- Currently participating in other interventional clinical research;
- 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).
Key Trial Info
Start Date :
January 31 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07362693
Start Date
January 31 2025
End Date
December 31 2028
Last Update
April 17 2026
Active Locations (1)
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1
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, 250014