ABPANCT07362693
A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA
An observational study of ABPA and Biologics, run by Qianfoshan Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ABPA, Biologics, Allergic Bronchopulmonary Aspergillosis (ABPA)
- What is being tested?
- Biologic Agent
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2025to 31 Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- 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
Jinan, Shandong, 250014
Qian Qi, Dr., +86 13706380314, qiqianqlh@163.com
About this study
Official title: 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.
- Conditions
- ABPA, Biologics, Allergic Bronchopulmonary Aspergillosis (ABPA), Cohort Study, Allergic Bronchopulmonary Aspergillosis, Efficacy and Safety
- Being tested
- Biologic Agent
- Keywords
- abpa, Allergic Bronchopulmonary Aspergillosis, Biologics
- Medical subject headings
- Aspergillosis, Allergic Bronchopulmonary, Invasive Pulmonary Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic AgentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Observation group: on the basis of the original standard drug treatment, combined with biological ag | Not described Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year and 2years
Secondary outcomes (14)
8-week treatment response rate
Measured: 8 weeks
Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis
Measured: 2 years
The time to the first exacerbation
Measured: 2 years
The number of times achieved remission
Measured: 2 years
Daily oral glucocorticoid use rate/average daily oral glucocorticoid dose/cumulative oral glucocorticoid dose
Measured: 2 years
Proportion of patients who remain in remission after glucocorticoids are stopped
Measured: 2 years
The use of antifungal drugs
Measured: 2 years
asthma control test(ACT)
Measured: 2 years
Serum total IgE
Measured: 2 years
All-cause mortality
Measured: 2 years
Aspergillus fumigatus sIgE
Measured: 2 years
Aspergillus fumigatus sIgG
Measured: 2 years
peripheral blood eosinophil count
Measured: 2 years
Results of exhaled nitric oxide test
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start31 Jan 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ABPAStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Qi, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362693
- Sponsor's protocol ID
- ABPA-002
- Status last verified
- Dec 2025
- First submitted
- 27 Dec 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observational Cohort Study on the Efficacy and Safety of Biological Agents in Patients With Allergic Bronchopulmonary Aspergillosis
- ClinicalTrials.gov ID
- NCT07362693
- Acronym / sponsor ID
- ABPA-002
- Conditions
- ABPA, Biologics, Allergic Bronchopulmonary Aspergillosis (ABPA), Cohort Study, Allergic Bronchopulmonary Aspergillosis, Efficacy and Safety
- Keywords
- abpa, Allergic Bronchopulmonary Aspergillosis, Biologics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biologic AgentOn 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. | Drug | Observation group: on the basis of the original standard drug treatment, combined with biological ag |
Primary outcome
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
14 secondary outcomes
8-week treatment response rate
Time frame: 8 weeks
Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis
Time frame: 2 years
The time to the first exacerbation
Time frame: 2 years
The number of times achieved remission
Time frame: 2 years
Daily oral glucocorticoid use rate/average daily oral glucocorticoid dose/cumulative oral glucocorticoid dose
Time frame: 2 years
Proportion of patients who remain in remission after glucocorticoids are stopped
Time frame: 2 years
The use of antifungal drugs
Time frame: 2 years
asthma control test(ACT)
Time frame: 2 years
Serum total IgE
Time frame: 2 years
All-cause mortality
Time frame: 2 years
Aspergillus fumigatus sIgE
Time frame: 2 years
Aspergillus fumigatus sIgG
Time frame: 2 years
peripheral blood eosinophil count
Time frame: 2 years
Results of exhaled nitric oxide test
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ABPA and Biologics, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Qi, Dr. (+86 13706380314, qiqianqlh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of exacerbations (annual exacerbation rate) (time frame: 1 year and 2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.