Status:

RECRUITING

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

Lead Sponsor:

Qianfoshan Hospital

Conditions:

ABPA

Biologics

Eligibility:

All Genders

18+ years

Brief Summary

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

Eligibility Criteria

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).

Key Trial Info

Start Date :

January 31 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2028

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT07362693

Start Date

January 31 2025

End Date

December 31 2028

Last Update

April 17 2026

Active Locations (1)

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Page 1 of 1 (1 locations)

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

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