A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA

Qianfoshan Hospital

Status: Not yet enrolling

Conditions: Allergic Bronchopulmonary Aspergillosis; Biologics; ABPA; Cohort Study; Allergic Bronchopulmonary Aspergillosis (ABPA); Efficacy and Safety

Treatments: Drug: Biologic Agent

Study type: Observational

Funder types: Other

Identifiers

NCT07362693

ABPA-002

Details and patient eligibility

About

To evaluate the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

50 participants in 2 patient groups

Observation group: on the basis of the original standard drug treatment, combined with biological ag

Treatment:

Drug: Biologic Agent

The control group only received standard drug treatment (oral glucocorticoids with or without oral a

Description:

The standard medical regimen was oral prednisone (0.5mg/Kg/ day for 4 weeks, 0.25mg/Kg/ day for 4 weeks, followed by 0.125mg/Kg/ day for 4 weeks, followed by a reduction of 5mg every 2 weeks until discontinuation) with or without oral voriconazole (200mg bid, 1 hour before or after meals).