ABPANCT07362667
A Study of the Efficacy and Safety of Bronchoscopic Airway Clearance and Amphotericin B Spraying in Patients With ABPA
An observational study of ABPA and Allergic Bronchopulmonary Aspergillosis, run by Qianfoshan Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of bronchoscopic airway clearance and amphotericin B spraying in the treatment of allergic bronchopulmonary aspergillosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ABPA, Allergic Bronchopulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis (ABPA)
- What is being tested?
- The patients were treated with bronchoscopic airway clearance and amphotericin B spraying
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2026to 31 Dec 2028
- 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 patients with acute exacerbation of allergic bronchopulmonary aspergillosis after drug withdrawal.
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), and the presence of mucus plugs or hyperattenuated mucus confirmed by chest high-resolution CT (HRCT).
- Active disease: Newly diagnosed allergic bronchopulmonary aspergillosis or an acute exacerbation after discontinuation of treatment (defined as a > 14 day history of clinical worsening or radiographic progression of allergic bronchopulmonary aspergillosis and a ≥50% increase in total serum IgE from the last recorded value during the stable phase, excluding other causes of the acute exacerbation) in patients with previously diagnosed allergic bronchopulmonary aspergillosis.
- Age ≥ 18 years old.
Who cannot join
- Allergic bronchopulmonary aspergillosis - serotype (i.e., meets the diagnostic criteria for allergic bronchopulmonary aspergillosis, but chest CT shows no obvious abnormality);
- Patients with absolute or relative contraindications to electronic bronchoscopy;
- Known history of allergy to amphotericin B or any of its excipients;
- Patients with bronchiectasis caused by human immunodeficiency virus infection, active tuberculosis, pulmonary malignant tumor or other non-allergic bronchopulmonary aspergillosis;
- Combined with other diseases requiring long-term systemic use of glucocorticoids or immunosuppressants (such as autoimmune diseases);
- Patients with previous or current smoking history;
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- 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 Bronchoscopic Airway Clearance and Amphotericin B Spraying in Patients With Allergic Bronchopulmonary Aspergillosis
To evaluate the efficacy and safety of bronchoscopic airway clearance and amphotericin B spraying in the treatment of allergic bronchopulmonary aspergillosis
- Conditions
- ABPA, Allergic Bronchopulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis (ABPA), Airway Clearance, Mucus Plug, Amphotericin B
- Being tested
- The patients were treated with bronchoscopic airway clearance and amphotericin B spraying
- Keywords
- Allergic Bronchopulmonary Aspergillosis, ABPA, Amphotericin B, bronchoscope, Airway Clearance, mucus plug
- Medical subject headings
- Aspergillosis, Allergic Bronchopulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The patients were treated with bronchoscopic airway clearance and amphotericin B sprayingProcedure or surgery
In addition to standard medical therapy (oral glucocorticoids with or without oral antifungal agents), bronchoscopic airway clearance and bronchoscopic spraying of amphotericin B (depending on the effectiveness of bronchoscopic mucus plug removal, At least one time of bronchoscopic airway clearance and amphotericin B spraying). 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 | The observation group was treated with standard drug therapy (oral glucocorticoids combined or not combined with oral antifungal drugs), combined with bronchoscopic airway clearance and amphotericin B spraying treatment Receives: Procedure: The patients were treated with bronchoscopic airway clearance and amphotericin B spraying | |
| Control group | Control group: The control group was treated with standard drug therapy (oral glucocorticoids with or without oral antifungal drugs). The previous treatment for bronchial asthma was maintained, including inhaled corticosteroids + long-acting β-receptor agonists, leukotriene receptor antagonists, etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic response rate after 4 months of treatment
Radiographic remission: defined as the removal of mucus plugs in the airway on radiographic examination
Measured: 4 months
Immunological remission rate after 4 months of treatment
Immunological remission: defined as at least a 50% decrease in total serum IgE from baseline
Measured: 4 months
The remission rate of clinical symptoms after 4 months of treatment
Clinical symptom relief: The semi-quantitative rating of clinical symptoms was evaluated using Likert scores with at least 50% improvement in symptoms
Measured: 4 months
Secondary outcomes (11)
Number of acute exacerbations within 1 year of drug withdrawal after 4 months of treatment
Measured: 1 year
Number of acute exacerbations within 2 years after 4 months of treatment
Measured: 2 years
Treatment response rate at 8 weeks
Measured: 8 weeks
Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis
Measured: 2 years
Time from discontinuation to first exacerbation
Measured: 2 years
After drug withdrawal, the number of patients who achieved treatment remission
The remission phase was defined as sustained (>6 months) clinical-radiologic improvement in the absence of (or discontinuation of) glucocorticoid therapy and the absence of an increase in total serum IgE of 50% or more from the last recorded value during the stable phase
Measured: 2 years
Quality of life score (AQLQ or mini-AQLQ)
Measured: 2 years
Serum total IgE
Measured: 2 years
All-cause mortality
Measured: 2 years
psychological Scale (Hospital Anxiety and Depression Scale, HADS)
Measured: 2 years
Aspergillus fumigatus sIgE
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 start10 Jan 2026
- 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
- 44 participants (estimated)
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
- NCT07362667
- Sponsor's protocol ID
- ABPA-001
- Status last verified
- Dec 2025
- First submitted
- 27 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 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 Bronchoscopic Airway Clearance and Amphotericin B Spraying in Patients With Allergic Bronchopulmonary Aspergillosis
- ClinicalTrials.gov ID
- NCT07362667
- Acronym / sponsor ID
- ABPA-001
- Conditions
- ABPA, Allergic Bronchopulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis (ABPA), Airway Clearance, Mucus Plug, Amphotericin B
- Keywords
- Allergic Bronchopulmonary Aspergillosis, ABPA, Amphotericin B, bronchoscope, Airway Clearance, mucus plug
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 10 Jan 2026 (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 bronchoscopic airway clearance and amphotericin B spraying in the treatment of allergic bronchopulmonary aspergillosis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | Procedure: The patients were treated with bronchoscopic airway clearance and amphotericin B sprayingThe observation group was treated with standard drug therapy (oral glucocorticoids combined or not combined with oral antifungal drugs), combined with bronchoscopic airway clearance and amphotericin B spraying treatment |
| Control group | – | –Control group: The control group was treated with standard drug therapy (oral glucocorticoids with or without oral antifungal drugs). The previous treatment for bronchial asthma was maintained, including inhaled corticosteroids + long-acting β-receptor agonists, leukotriene receptor antagonists, etc. |
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 patients with acute exacerbation of allergic bronchopulmonary aspergillosis after drug withdrawal.
Key inclusion criteria (3 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), and the presence of mucus plugs or hyperattenuated mucus confirmed by chest high-resolution CT (HRCT).
- Active disease: Newly diagnosed allergic bronchopulmonary aspergillosis or an acute exacerbation after discontinuation of treatment (defined as a > 14 day history of clinical worsening or radiographic progression of allergic bronchopulmonary aspergillosis and a ≥50% increase in total serum IgE from the last recorded value during the stable phase, excluding other causes of the acute exacerbation) in patients with previously diagnosed allergic bronchopulmonary aspergillosis.
- Age ≥ 18 years old.
Key exclusion criteria (9 listed)
- Allergic bronchopulmonary aspergillosis - serotype (i.e., meets the diagnostic criteria for allergic bronchopulmonary aspergillosis, but chest CT shows no obvious abnormality);
- Patients with absolute or relative contraindications to electronic bronchoscopy;
- Known history of allergy to amphotericin B or any of its excipients;
- Patients with bronchiectasis caused by human immunodeficiency virus infection, active tuberculosis, pulmonary malignant tumor or other non-allergic bronchopulmonary aspergillosis;
- Combined with other diseases requiring long-term systemic use of glucocorticoids or immunosuppressants (such as autoimmune diseases);
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 |
|---|---|---|
| The patients were treated with bronchoscopic airway clearance and amphotericin B sprayingIn addition to standard medical therapy (oral glucocorticoids with or without oral antifungal agents), bronchoscopic airway clearance and bronchoscopic spraying of amphotericin B (depending on the effectiveness of bronchoscopic mucus plug removal, At least one time of bronchoscopic airway clearance and amphotericin B spraying). The previous treatment for bronchial asthma was maintained, including inhaled corticosteroids + long-acting β-receptor agonists, leukotriene receptor antagonists, etc. | Procedure or surgery | Observation group |
Primary outcome
Radiographic response rate after 4 months of treatment
Time frame: 4 months
Radiographic remission: defined as the removal of mucus plugs in the airway on radiographic examination
Immunological remission rate after 4 months of treatment
Time frame: 4 months
Immunological remission: defined as at least a 50% decrease in total serum IgE from baseline
The remission rate of clinical symptoms after 4 months of treatment
Time frame: 4 months
Clinical symptom relief: The semi-quantitative rating of clinical symptoms was evaluated using Likert scores with at least 50% improvement in symptoms
11 secondary outcomes
Number of acute exacerbations within 1 year of drug withdrawal after 4 months of treatment
Time frame: 1 year
Number of acute exacerbations within 2 years after 4 months of treatment
Time frame: 2 years
Treatment response rate at 8 weeks
Time frame: 8 weeks
Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis
Time frame: 2 years
Time from discontinuation to first exacerbation
Time frame: 2 years
After drug withdrawal, the number of patients who achieved treatment remission
Time frame: 2 years
Quality of life score (AQLQ or mini-AQLQ)
Time frame: 2 years
Serum total IgE
Time frame: 2 years
All-cause mortality
Time frame: 2 years
psychological Scale (Hospital Anxiety and Depression Scale, HADS)
Time frame: 2 years
Aspergillus fumigatus sIgE
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 23 Jan 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 Allergic Bronchopulmonary Aspergillosis, 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 3 inclusion and 9 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 23 Jan 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?
Radiographic response rate after 4 months of treatment (time frame: 4 months). The study lists 3 primary outcomes in all. 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 23 Jan 2026.