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NCT Number: NCT07362693

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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, 250014, China

Location status: Recruiting

Location contact

Qian Qi, Dr.

CONTACT

[email protected]

+86 13706380314

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Biologic Agent

Drug

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.

Primary outcomes

  1. Number of exacerbations (annual exacerbation rate)

    Time frame: 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 outcomes

  1. 8-week treatment response rate

    Time frame: 8 weeks

  2. Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis

    Time frame: 2 years

  3. The time to the first exacerbation

    Time frame: 2 years

  4. The number of times achieved remission

    Time frame: 2 years

  5. Daily oral glucocorticoid use rate/average daily oral glucocorticoid dose/cumulative oral glucocorticoid dose

    Time frame: 2 years

  6. Proportion of patients who remain in remission after glucocorticoids are stopped

    Time frame: 2 years

  7. The use of antifungal drugs

    Time frame: 2 years

  8. asthma control test(ACT)

    Time frame: 2 years

  9. Serum total IgE

    Time frame: 2 years

  10. All-cause mortality

    Time frame: 2 years

  11. Aspergillus fumigatus sIgE

    Time frame: 2 years

  12. Aspergillus fumigatus sIgG

    Time frame: 2 years

  13. peripheral blood eosinophil count

    Time frame: 2 years

  14. Results of exhaled nitric oxide test

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Qi, Dr.

CONTACT

[email protected]

+86 13706380314

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study title

A Prospective, Multicenter, Observational Cohort Study on the Efficacy and Safety of Biological Agents in Patients With Allergic Bronchopulmonary Aspergillosis

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 23, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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