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

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

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

Study Overview

• Status: Recruiting
• Conditions: Cohort Study; Efficacy and Safety; Allergic Bronchopulmonary Aspergillosis; Biologics; ABPA; Allergic Bronchopulmonary Aspergillosis (ABPA)
• Intervention / Treatment: Drug: Biologic Agent

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Qian Qi, Dr.; Phone Number: +86 13706380314; Email: qiqianqlh@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
      • Contact: Qian Qi, Dr.; Phone Number: +86 13706380314; Email: qiqianqlh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with allergic bronchopulmonary aspergillosis included patients with newly diagnosed allergic bronchopulmonary aspergillosis and severe asthma, patients with refractory allergic bronchopulmonary aspergillosis, and patients with treatment-dependent allergic bronchopulmonary aspergillosis.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observation group: on the basis of the original standard drug treatment, combined with biological ag	Drug: 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.
The control group only received standard drug treatment (oral glucocorticoids with or without oral a; The standard medical regimen was oral prednisone (0.5mg/Kg/ day for 4 weeks, 0.25mg/Kg/ day for 4 weeks, followed by 0.125mg/Kg/ day for 4 weeks, followed by a reduction of 5mg every 2 weeks until discontinuation) with or without oral voriconazole (200mg bid, 1 hour before or after meals).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of exacerbations (annual exacerbation rate)	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	1 year and 2years

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality	2 years
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
Aspergillus fumigatus sIgE	2 years
Aspergillus fumigatus sIgG	2 years
peripheral blood eosinophil count	2 years
Results of exhaled nitric oxide test	2 years

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 27, 2025
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Biologics; Allergic Bronchopulmonary Aspergillosis; abpa
• Additional Relevant MeSH Terms: Invasive Fungal Infections; Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Bacterial Infections and Mycoses; Lung Diseases, Fungal; Mycoses; Pulmonary Aspergillosis; Aspergillosis; Invasive Pulmonary Aspergillosis; Aspergillosis, Allergic Bronchopulmonary; Biological Factors
• Other Study ID Numbers: ABPA-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No