RecruitingNot Applicable

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

China50 participantsStarted 2025-01-31

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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).

Number of exacerbations (annual exacerbation rate)

Timeframe: 1 year and 2years

NCT IDNCT07362693

SponsorQianfoshan Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12-31

Qian Qi, Dr.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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).