Recruiting NCT07362693
A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biologic Agent.
- Who it may be relevant to
- Registry conditions: ABPA, Biologics, Allergic Bronchopulmonary Aspergillosis (ABPA), Cohort Study. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Multicenter, Observational Cohort Study on the Efficacy and Safety of Biological Agents in Patients With Allergic Bronchopulmonary Aspergillosis
Overview
To evaluate the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis.
Interventions
- Drug Biologic Agent
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
Primary outcome measures
- Number of exacerbations (annual exacerbation rate) [Time frame: 1 year and 2years]
Secondary outcome measures (12)
- 8-week treatment response rate [Time frame: 8 weeks]
- Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis [Time frame: 2 years]
- The time to the first exacerbation [Time frame: 2 years]
- The number of times achieved remission [Time frame: 2 years]
- Daily oral glucocorticoid use rate/average daily oral glucocorticoid dose/cumulative oral glucocorticoid dose [Time frame: 2 years]
- Proportion of patients who remain in remission after glucocorticoids are stopped [Time frame: 2 years]
- The use of antifungal drugs [Time frame: 2 years]
- asthma control test(ACT) [Time frame: 2 years]
- Serum total IgE [Time frame: 2 years]
- All-cause mortality [Time frame: 2 years]
- Aspergillus fumigatus sIgE [Time frame: 2 years]
- Aspergillus fumigatus sIgG [Time frame: 2 years]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Department of Respiratory, The First Affiliated Hospital of Shandong First Medical Univers — Jinan
Identifiers
NCT: NCT07362693 · ABPA-002