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

NCT07362693 | Not Yet Recruiting FDA Drug

• 1 other identifier: ABPA-002
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ABPA; Biologics; Allergic Bronchopulmonary Aspergillosis (ABPA); Cohort Study; Allergic Bronchopulmonary Aspergillosis; Efficacy and Safety

Keywords

abpa; Allergic Bronchopulmonary Aspergillosis; Biologics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

Study Arms (2)

Observation group: on the basis of the original standard drug treatment, combined with biological ag

Drug: Biologic Agent

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).

Interventions

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.

Observation group: on the basis of the original standard drug treatment, combined with biological ag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (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, 250014, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, sputum, bronchoalveolar lavage fluid, stool, urine

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary; Invasive Pulmonary Aspergillosis

Interventions

Biological Factors

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Invasive Fungal Infections

Central Study Contacts

Qian Qi, Dr.

CONTACT

+86 13706380314; qiqianqlh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 23, 2026
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)