Allergic Bronchopulmonary AspergillosisNCT07757841
Real-World Effectiveness of Tezepelumab in Allergic Bronchopulmonary Aspergillosis
A study testing Tezepelumab in people with Allergic Bronchopulmonary Aspergillosis and Severe Asthma, run by Qianfoshan Hospital at 1 site in China.
Trial summary
An open-label study will evaluate effects of Tezepelumab 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?
- Tezepelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- 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
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
- 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
- Clinically important pulmonary disease other than asthma with allergic bronchopulmonary aspergillosis (i.e., chronic obstructive pulmonary disease (COPD), cystic fibrosis, sarcoidosis, and pulmonary fibrosis).
- History of anaphylaxis to any biologic therapy. Known history of allergy or hypersensitivity reaction to tezepelumab or any of its components.
- Currently pregnant, breastfeeding, or lactating women. Concurrent enrollment in another interventional or post-authorization safety study, unless it is observational.
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
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
Jinan, Shandong, 250014
Qian Qi, Dr., +86 13706380314, qiqianqlh@163.com
About this study
Official title: Effectiveness and Safety of Tezepelumab in Allergic Bronchopulmonary Aspergillosis (ABPA): a Prospective Study of Real-world Experience
An open-label study will evaluate effects of Tezepelumab 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 Tezepelumab injections (210 mg subcutaneous) administered every 4 weeks.
- Conditions
- Allergic Bronchopulmonary Aspergillosis, Severe Asthma, ABPA
- Being tested
- Tezepelumab
- Keywords
- ABPA, Tezepelumab
- 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.
TezepelumabDrug
210 mg (1.91 mL) Subcutaneous Solution
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Treatment | Experimental | Tezepelumab treatment will be given by injections administered every 4 weeks thereafter, for a total of 24 weeks of active treatment. Receives: Drug: Tezepelumab |
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 posted11 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT07757841
- Sponsor's protocol ID
- ABPA-007
- Status last verified
- Jun 2026
- First submitted
- 31 Jul 2026
- Last updated
- 11 Aug 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Tezepelumab in Allergic Bronchopulmonary Aspergillosis (ABPA): a Prospective Study of Real-world Experience
- ClinicalTrials.gov ID
- NCT07757841
- Acronym / sponsor ID
- ABPA-007
- Conditions
- Allergic Bronchopulmonary Aspergillosis, Severe Asthma, ABPA
- Keywords
- ABPA, Tezepelumab
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Aug 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 Tezepelumab 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 Tezepelumab injections (210 mg subcutaneous) administered every 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Treatment | Experimental | Drug: TezepelumabTezepelumab treatment will be given by injections administered every 4 weeks thereafter, for a total of 24 weeks of active treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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)
- (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
- 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
Key exclusion criteria (3 listed)
- Clinically important pulmonary disease other than asthma with allergic bronchopulmonary aspergillosis (i.e., chronic obstructive pulmonary disease (COPD), cystic fibrosis, sarcoidosis, and pulmonary fibrosis).
- History of anaphylaxis to any biologic therapy. Known history of allergy or hypersensitivity reaction to tezepelumab or any of its components.
- 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 |
|---|---|---|
| Tezepelumab210 mg (1.91 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 11 Aug 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?
A study testing Tezepelumab in people with Allergic Bronchopulmonary Aspergillosis and Severe Asthma, 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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 11 Aug 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 (+8613706380314, 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 11 Aug 2026.