Actively Recruiting
A Prospective, Multicenter, Observational Cohort Study on the Efficacy and Safety of Biological Agents in Patients With Allergic Bronchopulmonary Aspergillosis
Led by Qianfoshan Hospital · Updated on 2026-04-17
50
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis (ABPA), a condition that often affects people with severe bronchial asthma. The study follows guidelines from ISHAM for ABPA diagnosis and treatment, aiming to understand how biologics can impact this condition. This is a prospective, multicenter observational cohort study sponsored by Qianfoshan Hospital. Participants receive standard medical treatment consisting of oral prednisone with a tapering dose over several weeks, with or without oral voriconazole. Some patients also receive biological agents combined with this standard therapy for at least four months, following GINA2025 guidelines. The biologics are given alongside existing asthma treatments, such as inhaled corticosteroids and long-acting beta-agonists. The study compares groups receiving biologics plus standard treatment versus standard treatment alone. During the study, researchers monitor participants for one to two years, assessing the number of exacerbations, hospitalizations, time to first exacerbation, remission rates, glucocorticoid use, asthma control, and various immune markers such as serum IgE and eosinophil counts. Safety and overall mortality are also tracked. This extensive follow-up includes measuring treatment responses at eight weeks and ongoing assessments to evaluate long-term effects and disease control.
CONDITIONS
Brief Title
A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the diagnostic criteria of allergic bronchopulmonary aspergillosis according to ISHAM guidelines (2024 revision)
- Have severe bronchial asthma as the underlying disease
- Experienced an acute asthma attack in the past year
- Blood eosinophil count is at least 150 cells per microliter
- Age 18 years or older
You will not qualify if you...
- Have chronic obstructive pulmonary disease or bronchiectasis
- Known allergy to biological agents
- Have HIV infection, active pulmonary tuberculosis, or pulmonary malignant tumor
- Have other diseases requiring long-term systemic glucocorticoids or immunosuppressants
- Are pregnant or breastfeeding
- Currently participating in other interventional clinical research
- Any other condition that would prevent study participation, such as poor adherence, predicted survival less than 1 year, or severe mental illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 4 months
Participants receive biological agents combined with their original standard drug treatment for allergic bronchopulmonary aspergillosis and severe bronchial asthma, maintained for at least 4 months as recommended by guidelines.
Visits according to treatment schedule (not specifically defined)
Duration - Up to 2 years
Participants are observed for up to 2 years to assess exacerbations, hospitalizations, remission, medication use, and other health outcomes.
Periodic visits over 2 years (exact cadence not specified)
Trial Site Locations
Total: 1 location
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
Actively Recruiting
Research Team
Q
Qian Qi, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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