ABPA, Allergic Bronchopulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis (ABPA), Biologics, Cohort Study, Efficacy and Safety
Conditions
Keywords
abpa, Allergic Bronchopulmonary Aspergillosis, Biologics
Brief summary
To evaluate the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis.
Interventions
DRUGBiologic 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 receptor antagonists, etc.
Sponsors
Qianfoshan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of exacerbations (annual exacerbation rate) | 1 year and 2years | Acute exacerbations include acute exacerbation of allergic bronchopulmonary aspergillosis, acute exacerbation/attack of asthma, and acute exacerbation/bronchiectasis of infection. Acute exacerbation of allergic bronchopulmonary aspergillosis: in patients who have been diagnosed with allergic bronchopulmonary aspergillosis, persistent (\>14 days) clinical deterioration or worsening of imaging findings, accompanied by an increase in total serum IgE of \>50% from the last recorded value in the stable period, with no other cause of deterioration. Acute asthma exacerbation/exacerbation: worsening of respiratory symptoms for at least 48 hours without evidence of immunological or radiographic worsening of allergic bronchopulmonary aspergillosis; Acute exacerbation of infectious/bronchiectasis: clinical worsening for at least 48 hours, including cough, dyspnea, changes in sputum volume or texture, sputum purulence, fatigue, malaising, fever, or hemoptysis, without immunological or imaging worse |
Secondary
| Measure | Time frame |
|---|---|
| 8-week treatment response rate | 8 weeks |
| Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis | 2 years |
| The time to the first exacerbation | 2 years |
| The number of times achieved remission | 2 years |
| Daily oral glucocorticoid use rate/average daily oral glucocorticoid dose/cumulative oral glucocorticoid dose | 2 years |
| Proportion of patients who remain in remission after glucocorticoids are stopped | 2 years |
| The use of antifungal drugs | 2 years |
| asthma control test(ACT) | 2 years |
| Serum total IgE | 2 years |
| All-cause mortality | 2 years |
| Aspergillus fumigatus sIgE | 2 years |
| Aspergillus fumigatus sIgG | 2 years |
| peripheral blood eosinophil count | 2 years |
| Results of exhaled nitric oxide test | 2 years |
Countries
China
Contacts
CONTACTQian Qi, Dr.
Outcome results
None listed