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

Condition(s) studied

Investigational drug(s) / intervention(s)

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 receptor antagonists, etc.

Study summary

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

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

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