Allergic Bronchopulmonary Aspergillosis (ABPA)NCT07040332
Pathogenesis and Inflammatory Phenotype of Allergic Bronchopulmonary Aspergillosis
An observational study of Allergic Bronchopulmonary Aspergillosis (ABPA), run by Qianfoshan Hospital at 1 site in China.
Trial summary
This study aims to reveal the immune and inflammatory regulatory molecular mechanisms related to the progression of allergic bronchopulmonary aspergillosis (ABPA), and to build a precision typing based on inflammation and identify the biomarkers of typing, and to explore the clinical outcomes of different inflammatory… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Bronchopulmonary Aspergillosis (ABPA)
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2025to 31 Jan 2029
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients with allergic bronchopulmonary aspergillosis and fungal-sensitized asthma who were treated in several hospitals were included as the study objects, and the relatively normal ones who had no bronchial asthma and no fungal sensitization were matched by gender and age as the control group, and then the cohorts of patients with allergic bronchopulmonary aspergillosis, fungal-sensitized asthma and the control group were established.
Who may be able to join
- Meets the diagnostic criteria for allergic bronchopulmonary aspergillosis.
- Meets the diagnostic criteria for fungal-sensitized asthma.
Who cannot join
- Human immunodeficiency virus infection.
- Malignant tumor.
- Blood system disease.
- autoimmune system disease.
- History of pulmonary tuberculosis.
- Patients with a history of smoking or still smoking.
- Invasive pulmonary fungal disease.
- Contraindications electronic bronchoscopy
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
This study aims to reveal the immune and inflammatory regulatory molecular mechanisms related to the progression of allergic bronchopulmonary aspergillosis (ABPA), and to build a precision typing based on inflammation and identify the biomarkers of typing, and to explore the clinical outcomes of different inflammatory phenotypes.
- 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.
Other
No intervention
| Study group | Role | What they receive |
|---|---|---|
| allergic bronchopulmonary aspergillosis | Not described | |
| fungal-sensitized asthma | Not described | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total serum IgE
Measured: Up to 12 months
Secondary outcomes (2)
Aspergillus-specific IgE
Measured: Up to 12 months
Aspergillus-specific IgG
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start10 May 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Bronchopulmonary Aspergillosis (ABPA)Studies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, Fudan University, Guizhou Provincial People's Hospital, The First Hospital of Jilin University, Qilu Hospital of Shandong University
- Responsible party
- Principal investigator, Qian Qi, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040332
- Sponsor's protocol ID
- QFS-2025-074
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 4 Jul 2025
- 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 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogenesis and Inflammatory Phenotype of Allergic Bronchopulmonary Aspergillosis
- ClinicalTrials.gov ID
- NCT07040332
- Acronym / sponsor ID
- QFS-2025-074
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, Fudan University, Guizhou Provincial People's Hospital, The First Hospital of Jilin University, Qilu Hospital of Shandong University
- Study start
- 10 May 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 27 Jun 2025 (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.
This study aims to reveal the immune and inflammatory regulatory molecular mechanisms related to the progression of allergic bronchopulmonary aspergillosis (ABPA), and to build a precision typing based on inflammation and identify the biomarkers of typing, and to explore the clinical outcomes of different inflammatory phenotypes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| allergic bronchopulmonary aspergillosis | – | – |
| fungal-sensitized asthma | – | – |
| control group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with allergic bronchopulmonary aspergillosis and fungal-sensitized asthma who were treated in several hospitals were included as the study objects, and the relatively normal ones who had no bronchial asthma and no fungal sensitization were matched by gender and age as the control group, and then the cohorts of patients with allergic bronchopulmonary aspergillosis, fungal-sensitized asthma and the control group were established.
Key inclusion criteria (2 listed)
- Meets the diagnostic criteria for allergic bronchopulmonary aspergillosis.
- Meets the diagnostic criteria for fungal-sensitized asthma.
Key exclusion criteria (8 listed)
- Human immunodeficiency virus infection.
- Malignant tumor.
- Blood system disease.
- autoimmune system disease.
- History of pulmonary tuberculosis.
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 |
|---|---|---|
| No intervention | Other | allergic bronchopulmonary aspergillosis, control group, fungal-sensitized asthma |
Primary outcome
Total serum IgE
Time frame: Up to 12 months
2 secondary outcomes
Aspergillus-specific IgE
Time frame: Up to 12 months
Aspergillus-specific IgG
Time frame: Up to 12 months
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 4 Jul 2025.
- 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 Allergic Bronchopulmonary Aspergillosis (ABPA), 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 2 inclusion and 8 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 4 Jul 2025. 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, Prof. (+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?
Total serum IgE (time frame: Up to 12 months). 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 4 Jul 2025.