Allergic Bronchopulmonary AspergillosisNCT07530770
Real-World Effectiveness of Benralizumab in Allergic Bronchopulmonary Aspergillosis
An observational study of Allergic Bronchopulmonary Aspergillosis and Severe Asthma, run by Qianfoshan Hospital at 2 sites in China.
Trial summary
An open-label study will evaluate effects of Benralizumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Allergic Bronchopulmonary Aspergillosis, Severe Asthma, ABPA
- What is being tested?
- Fasenra
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2025to 1 Dec 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Female and Male patients aged 18-75 years inclusively at the time of Visit 1 with a physician diagnosis of Allergic Bronchopulmonary Aspergillosis has met the ISHAM Working Group Diagnostic Criteria for ABPA Severe chronic asthma (for at least 12 months) requiring treatment with high dose ICS plus asthma controller prior to Visit 1 History of at least 2 asthma exacerbations while on ICS plus another asthma controller (see inclusion criterion 2 for examples) that required treatment with systemic corticosteroids (IM, IV, or oral) in the 12 months prior to Visit 1. For patients receiving oral corticosteroids as a maintenance therapy, an exacerbation is defined as a temporary increase of their maintenance dose for a minimum of 3 days. Weight > 40kg
Who may be able to join
- Female and Male patients aged 18-75 years inclusively at the time of Visit 1 with a physician diagnosis of Allergic Bronchopulmonary Aspergillosis has met the ISHAM Working Group Diagnostic Criteria for ABPA:
- Predisposing condition: Bronchial asthma Obligatory criteria (both should be present)
- Type I aspergillus skin test positive (immediate cutaneous hypersensitivity Aspergillus antigen) or elevated IgE level against Aspergillus fumigatus (Af) Aspergillus niger or Aspergillus flavus may be eligible provided antigen-specific IgE and IgG measurements are available for use.
- Elevated total IgE levels (>1,000IU/mL) Other criteria (at least two of three)
- Presence of precipitating or IgG antibodies against Af in serum Radiographic pulmonary opacities consistent with ABPA Total eosinophil count >500 cells/uL in steroid naïve patients (may be historical)
- (if the patient meets all other criteria, an IgE value <1,000 IU/mL may be acceptable) Severe chronic asthma (for at least 12 months) requiring treatment with high dose ICS plus asthma controller prior to Visit 1
Show all 10Show fewer
- Other acceptable asthma controllers include long acting bronchodilators (e.g. a long acting beta-agonist (LABA) or long-acting muscarinic antagonists (LAMA)), a leukotriene inhibitor, theophylline preparations and/or maintenance OCS (daily or every other day OCS requirement in order to maintain asthma control Documented current treatment with high daily doses of ICS ( >500ug of FP equivalent) plus at least one other asthma controller for at least 3 months prior to Visit 1
- For ICS/LABA combination preparation, highest-strength maintenance doses approved in the U.S. will meet this criterion If the ICS and the other asthma controller therapies are given by separate inhalers, then the patient must be on a high daily ICS dose for 3 months prior to entering the study.
- History of at least 2 asthma exacerbations while on ICS plus another asthma controller (see inclusion criterion 2 for examples) that required treatment with systemic corticosteroids (IM, IV, or oral) in the 12 months prior to Visit 1. For patients receiving oral corticosteroids as a maintenance therapy, an exacerbation is defined as a temporary increase of their maintenance dose for a minimum of 3 days.
- Weight > 40kg
Who cannot join
- Clinical important pulmonary disease other than asthma with allergic bronchopulmonary aspergillosis (ie. chronic obstructive pulmonary disease (COPD), cystic fibrosis, sarcoid, and pulmonary fibrosis) History of anaphylaxis to any biologic therapy Known history of allergy or hypersensitivity reaction to benralizumab or any of its components Current smokers or former smokers with a smoking history of > 10 pack years. A former smoker is defined as a patient who quit smoking at least 6 months prior to Visit 1.
- Currently pregnant, breastfeeding, or lactating women Concurrent enrollment in another interventional or post-authorization safety study, unless it is observational.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 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
- Recruiting
Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250014
Qian Qi, Doctor, +86 13706380314, qiqianqlh@163.com
About this study
Official title: Effectiveness and Safety of Benralizumab in Allergic Bronchopulmonary Aspergillosis (ABPA): a Prospective Study of Real-world Experience
An open-label study will evaluate effects of Benralizumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis
Read the detailed description
Subjects who have been identified to have severe asthma with ABPA will be consented and enrolled in the study to receive benralizumab injections administered every 4 weeks for the first 3 injections with an additional injection eight weeks to follow for a total of 16 weeks active treatment with a follow-up/termination visit eight weeks from the last injection. The termination visit will occur week 24 for subjects who complete the study treatment. Subjects who receive the first dose of benralizumab but withdraw from the study or terminate study treatment for any reason should complete all the procedures outlined for the termination visit.
- Conditions
- Allergic Bronchopulmonary Aspergillosis, Severe Asthma, ABPA
- Being tested
- Fasenra
- Keywords
- ABPA, Benralizumab
- Medical subject headings
- Aspergillosis, Allergic Bronchopulmonary, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FasenraDrug
Also called Benralizumab
30 Mg/mL Subcutaneous Solution
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Treatment | Benralizumab treatment will be given by injections administered every 4 weeks for the first 3 injections with an additional injection eight weeks to follow for a total of 16 weeks active treatment Receives: Drug: Fasenra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steroid requiring exacerbations
Number of asthma exacerbations requiring the initiation of (or temporary increase in) systemic corticosteroids in severe asthma complicated by ABPA
Measured: 26 Weeks
Secondary outcomes (3)
Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire
The change from baseline score in Saint George Respiratory Questionnaire. The Saint George Respiratory Questionnaire (SGRQ) total score ranges from 0 to 100. Higher scores indicate a worse outcome (greater health impairment/poorer quality of life)
Measured: 26 Weeks
Asthma Control as assessed by Asthma Control Questionnaire 6
The change from baseline score in Asthma Control Questionnaire 6. ACQ-6 scores range from 0 to 6, where higher scores represent poorer asthma control. A score ≤0.75 indicates well-controlled asthma, while a score ≥1.5 indicates uncontrolled asthma.
Measured: 26 Weeks
Lung Function (FEV1)
The FEV1 change from baseline to End of Treatment
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Sep 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Bronchopulmonary AspergillosisStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Qi, Qianfoshan Hospital
- Investigators
- Qian Qi, Study director, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530770
- Sponsor's protocol ID
- ABPA-003
- Status last verified
- Aug 2025
- First submitted
- 7 Dec 2025
- Last updated
- 21 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Benralizumab in Allergic Bronchopulmonary Aspergillosis (ABPA): a Prospective Study of Real-world Experience
- ClinicalTrials.gov ID
- NCT07530770
- Acronym / sponsor ID
- ABPA-003
- Conditions
- Allergic Bronchopulmonary Aspergillosis, Severe Asthma, ABPA
- Keywords
- ABPA, Benralizumab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 15 Apr 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.
An open-label study will evaluate effects of Benralizumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis
Detailed description
Subjects who have been identified to have severe asthma with ABPA will be consented and enrolled in the study to receive benralizumab injections administered every 4 weeks for the first 3 injections with an additional injection eight weeks to follow for a total of 16 weeks active treatment with a follow-up/termination visit eight weeks from the last injection. The termination visit will occur week 24 for subjects who complete the study treatment. Subjects who receive the first dose of benralizumab but withdraw from the study or terminate study treatment for any reason should complete all the procedures outlined for the termination visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Treatment | – | Drug: FasenraBenralizumab treatment will be given by injections administered every 4 weeks for the first 3 injections with an additional injection eight weeks to follow for a total of 16 weeks active treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female and Male patients aged 18-75 years inclusively at the time of Visit 1 with a physician diagnosis of Allergic Bronchopulmonary Aspergillosis has met the ISHAM Working Group Diagnostic Criteria for ABPA Severe chronic asthma (for at least 12 months) requiring treatment with high dose ICS plus asthma controller prior to Visit 1 History of at least 2 asthma exacerbations while on ICS plus another asthma controller (see inclusion criterion 2 for examples) that required treatment with systemic corticosteroids (IM, IV, or oral) in the 12 months prior to Visit 1. For patients receiving oral corticosteroids as a maintenance therapy, an exacerbation is defined as a temporary increase of their maintenance dose for a minimum of 3 days. Weight > 40kg
Key inclusion criteria (10 listed)
- Female and Male patients aged 18-75 years inclusively at the time of Visit 1 with a physician diagnosis of Allergic Bronchopulmonary Aspergillosis has met the ISHAM Working Group Diagnostic Criteria for ABPA:
- Predisposing condition: Bronchial asthma Obligatory criteria (both should be present)
- Type I aspergillus skin test positive (immediate cutaneous hypersensitivity Aspergillus antigen) or elevated IgE level against Aspergillus fumigatus (Af) Aspergillus niger or Aspergillus flavus may be eligible provided antigen-specific IgE and IgG measurements are available for use.
- Elevated total IgE levels (>1,000IU/mL) Other criteria (at least two of three)
- Presence of precipitating or IgG antibodies against Af in serum Radiographic pulmonary opacities consistent with ABPA Total eosinophil count >500 cells/uL in steroid naïve patients (may be historical)
Key exclusion criteria (2 listed)
- Clinical important pulmonary disease other than asthma with allergic bronchopulmonary aspergillosis (ie. chronic obstructive pulmonary disease (COPD), cystic fibrosis, sarcoid, and pulmonary fibrosis) History of anaphylaxis to any biologic therapy Known history of allergy or hypersensitivity reaction to benralizumab or any of its components Current smokers or former smokers with a smoking history of > 10 pack years. A former smoker is defined as a patient who quit smoking at least 6 months prior to Visit 1.
- Currently pregnant, breastfeeding, or lactating women Concurrent enrollment in another interventional or post-authorization safety study, unless it is observational.
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 |
|---|---|---|
| FasenraAlso: Benralizumab30 Mg/mL Subcutaneous Solution | Drug | Experimental: Treatment |
Primary outcome
Number of steroid requiring exacerbations
Time frame: 26 Weeks
Number of asthma exacerbations requiring the initiation of (or temporary increase in) systemic corticosteroids in severe asthma complicated by ABPA
3 secondary outcomes
Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire
Time frame: 26 Weeks
Asthma Control as assessed by Asthma Control Questionnaire 6
Time frame: 26 Weeks
Lung Function (FEV1)
Time frame: 26 Weeks
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 21 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Allergic Bronchopulmonary Aspergillosis
Not yet recruiting
Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
Allergic Bronchopulmonary Aspergillosis, ABPA
RecruitingObservational study
T2AIR: Real-World Efficacy and Safety of Biologics Targeting Type 2 Inflammation in Asthma and COPD
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Not yet recruiting
Real-World Effectiveness of Tezepelumab in Allergic Bronchopulmonary Aspergillosis
Allergic Bronchopulmonary Aspergillosis, Severe Asthma
RecruitingObservational study
ML-Based ABPA Recurrence Prediction and Clinical Utility
ABPA, Allergic Bronchopulmonary Aspergillosis
RecruitingObservational study
Fungal Status and Prognosis in ABPA
ABPA, Allergic Bronchopulmonary Aspergillosis
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.
Qian Qi study director
Shandong First Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Bronchopulmonary Aspergillosis and Severe Asthma, run by Qianfoshan Hospital at 2 sites 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 10 inclusion and 2 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 21 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 2 sites 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 steroid requiring exacerbations (time frame: 26 Weeks). 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 21 Apr 2026.