Allergic Bronchopulmonary Aspergillosis with Asthma as the Underlying Disease
Conditions
Interventions
Placebo Group:Subcutaneous injection of placebo
Omalizumab Group:Subcutaneous injection of omalizumab
Sponsors
The First Affiliated Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–80 years, any gender; 2. Diagnosed with ABPA by researchers according to the 2024 ISHAM diagnostic criteria, or newly confirmed during the screening period; ABPA diagnostic criteria (ISHAM 2024): (1) Presence of a predisposing underlying condition (such as asthma, cystic fibrosis, chronic obstructive pulmonary disease, or bronchiectasis); (2) Serum Aspergillus-specific IgE = 0.35 kUA/L; (3) Serum total IgE > 500 IU/mL; (4) At least two of the following additional criteria simultaneously: 1) Peripheral blood eosinophil count = 500 cells/µL; 2) Chest high-resolution CT (HRCT) showing typical ABPA features (such as bronchiectasis, mucus plugs, migratory infiltrates, or high-density mucus); 3) Elevated serum Aspergillus-specific IgG antibodies. 3. Meets the diagnostic criteria for bronchial asthma (according to GINA 2025 guidelines); 4. Must meet one of the following ABPA populations: (1) Newly diagnosed ABPA patients; (2) Treated active ABPA patients (receiving systemic glucocorticoid therapy): 1) At least one ABPA exacerbation within the 1 year prior to randomization; 2) In the past 12 months, a clear history of treatment with moderate or higher doses of systemic glucocorticoids (OCS, prednisone equivalent), and meeting any of the following conditions: cumulative dose >= 500 mg; or having received >= 2 separate courses (each course lasting >= 14 days); if undergoing OCS maintenance therapy at baseline (prednisone equivalent dose >= 5 mg/day), the dose must have been stable for >= 4 weeks before randomization. (3) ABPA patients reactivated after biologic therapy: 1) At least one ABPA exacerbation within the 1 year prior to randomization; 2) Previously received biologic therapy for ABPA/asthma (e.g., anti-IL-5/IL-5R, anti-IL-4Ra, anti-TSLP, or anti-IgE), and has discontinued the drug for at least 5.5 half-lives (or as per the washout period specified in the instructions); currently requires restarting systemic therapy due to ABPA activity, and the investigator determines a need for optimized treatment. 3) If planning to restart or combine with OCS, the requirements regarding OCS treatment history and stability described in item (2) above must also be met.
Exclusion criteria
Exclusion criteria: 1. Screen for respiratory tract infections requiring systemic treatment that occurred within the previous 4 weeks; 2. Asthma with comorbidities other than ABPA, including other significant chronic pulmonary diseases (e.g., interstitial lung disease, bronchopulmonary dysplasia) or pulmonary/systemic diseases associated with eosinophilia (e.g., eosinophilic granulomatosis, eosinophilic pneumonia, etc.); 3. Pregnant or lactating women; 4. Diagnosis of worm-type parasitic infection within the previous 24 weeks. 5. History of malignancy within the past 5 years (except for cervical carcinoma in situ that has been in remission for >=12 months, basal cell carcinoma, or superficial squamous cell skin cancer); 6.) Presence of a severe acute illness or serious adverse event (SAE) requiring systemic treatment within the prior 4 weeks; 7. A prior confirmed diagnosis of immunodeficiency disorders (including primary immunodeficiency and acquired immunodeficiency syndrome); 8. Concomitant primary adrenal insufficiency or irreversible secondary adrenal insufficiency; 9. Presence of active infection or severe, uncontrolled comorbidities, such as active pulmonary infection, tuberculosis, uncontrolled arrhythmia, unstable angina, acute myocardial infarction, acute heart failure, or acute hepatic/renal insufficiency. 10. Individuals who have used other biologics within the past 12 months and discontinued them less than 5.5 half-lives ago; 11. Administration of live attenuated vaccines is prohibited within 4 weeks prior to baseline or during the study. 12. Current smokers or e-cigarette users, individuals who quit smoking or continue using e-cigarettes within 6 months prior to randomization, or those with a smoking history of >=10 pack-years are ineligible for enrollment. 13. Patients who have received systemic antifungal therapy (particularly triazole agents, such as itraconazole, voriconazole, and posaconazole) continuously within the preceding 8 weeks are excluded; prior or short-term (<=14 days) antifungal treatment for a confirmed non-study fungal infection is permitted. 14. Other conditions deemed unsuitable for enrollment by the investigator (e.g., poor compliance, presence of study contraindications, or anticipated inability to complete follow-up).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of acute exacerbations randomized to Cycle 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| HRCT Score;Nitric oxide (FeNO) levels;Proportion of participants achieving clinical remission at Week 24;Pulmonary Function Indicators;Glucocorticoid Usage;Symptom Control and Quality of Life; | — |
Countries
China
Contacts
Public ContactCao Chao
The First Affiliated Hospital of Ningbo University
Outcome results
None listed