Can a single injection tame severe asthma in fungal allergy?
NCT ID NCT07757841
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This study is testing whether tezepelumab, an injectable medication, can help people with severe asthma caused by allergic bronchopulmonary aspergillosis (ABPA), a condition where the immune system overreacts to certain fungi. The trial will enroll 10 adults aged 18 to 75 who have both ABPA and severe asthma. Researchers will track how many asthma attacks require steroid treatment and whether participants report better quality of life, to see if tezepelumab offers a new way to manage this challenging condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tezepelumab
- What this could lead to
- If effective, tezepelumab could offer a new way to control severe asthma in people with ABPA, potentially reducing the need for steroid bursts and improving daily life.
- What could go wrong
- This is a very small, early real-world study with only 10 participants, so results may not apply broadly. Tezepelumab may not reduce asthma attacks in this specific condition, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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 Exclusion Criteria: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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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, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an injected biologic cut steroid Flare-Ups in a Tough-to-Treat asthma complication?
- A radioactive 'Iron Magnet' could reveal hidden lung fungus
- Could a simple exercise programme boost asthma remission?
- A two-step strategy: biologic drug may pave the way for immunotherapy in severe olive pollen asthma
- AI model aims to predict dangerous lung Flare-Ups in ABPA patients
- Could a biologic drug free severe asthma patients from High-Dose steroids?