A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA
A Prospective, Multicenter, Observational Cohort Study on the Efficacy and Safety of Biological Agents in Patients With Allergic Bronchopulmonary Aspergillosis
Qianfoshan Hospital
50 participants
Jan 31, 2025
OBSERVATIONAL
Conditions
Summary
To evaluate the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis.
Eligibility
Inclusion Criteria5
- 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 Criteria7
- 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).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
On the basis of the original standard drug treatment, biological agents were combined. All patients received at least 4 months of the same biologic agent, as recommended by the GINA2025 guidelines and assessed for response. It can be administered simultaneously with standard medical therapy or as maintenance therapy for 4 months on standard medical therapy. The previous treatment for bronchial asthma was maintained, including inhaled corticosteroids + long-acting β-receptor agonists, leukotriene receptor antagonists, etc.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07362693