AsthmaNCT07136025
The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System
A study testing Individualized cluster management and Routine asthma treatment in people with Asthma, run by Beijing Chao Yang Hospital at 10 sites in China.
Trial summary
Severe asthma is a complex and heterogeneous disease. Patients with severe asthma can present with different types of airway inflammation, and are often accompanied by a variety of comorbidities and risk factors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Individualized cluster management and Routine asthma treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 10 sitesChina
- Study dates
- 1 Feb 2025to 31 Jan 2029
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, and <80 years with a definite diagnosis of asthma for at least 6 months
- Patients met the 2024 GINA criteria for severe asthma, which was defined as "uncontrolled" asthma (frequent asthma symptoms, or frequent acute exacerbations) despite high-dose inhaled corticosteroids (ICS) plus long-acting β2-receptor antagonists (LABAs), or worsening of symptoms after slight tapering of high-dose therapy.
- They were willing to accept multi-disciplinary and multi-dimensional evaluation and signed informed consent
- Informed consent was obtained and patients were able to participate in the study and 6-month follow-up according to the protocol
Who cannot join
- The presence of numerous other lung tissue destructive diseases, such as severe bronchiectasis or pulmonary tuberculosis.
- Chest surgery or abdominal surgery in the past 3 months
- Eye surgery had been performed within the past 3 months
- Myocardial infarction within the previous 3 months
- Anti-tuberculosis treatment is ongoing
- Women who are pregnant and lactating
Show all 11Show fewer
- Macrolide use within 4 weeks before the screening period
- Treatment with anti-ige, anti-IL-5, or anti-IL-5R within 4 weeks before the screening period
- Inhaled ICS+LABA+ long-acting anticholinergic agent (LAMA) for 4 weeks prior to the screening period 4. Allergy to macrolides
- QTc interval prolongation >480ms
- Taking medications that interact with azithromycin, causing QTc prolongation or existing ECG abnormalities, may lead to arrhythmia
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Kewu Huang, 8613601234681, kewuhuang@126.com
- Recruiting
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality
Xiaoning Bu, 8613641000837
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Nan Su, 8613501157632, sunan7632@163.com
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Yan Chen, 8613508471738, chenyan99727@csu.edu.cn
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Qingling Zhang, 8613609068871, zqling@gzhmu.edu.cn
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Fen Lan, 8615824446949, whlanfen@126.com
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Shanghai, Shanghai Municipality
Guochao Shi, 8613918462035
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning
Hui Shen, 8618842320568, shenhuiat@126.com
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
Lei Wang, 8613935107849, wanglei1@sxbqeh.com.cn
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Yali Guo, guoyali198512@163.com
About this study
Severe asthma is a complex and heterogeneous disease. Patients with severe asthma can present with different types of airway inflammation, and are often accompanied by a variety of comorbidities and risk factors. Identification of potentially modifiable factors affecting prognosis, that is, "treatable characteristics", and individualized bundle management based on these characteristics may help to improve the quality of life of patients with asthma and improve the level of asthma control. Through joint research, this project aims to evaluate the treatable characteristics of asthma in patients with severe asthma in tertiary hospitals across the country, including lung function, fractional exhaled nitric oxide, blood routine, allergen IgE, chest CT, and a detailed questionnaire. The distribution of treatable characteristics of patients with severe asthma and its impact on the quality of life or asthma control level of patients were investigated. For patients with severe asthma, multidisciplinary consultation and shared decision-making were used to establish an individualized bundle management model based on the treatable characteristics of severe asthma. A 6-month randomized parallel controlled clinical trial was conducted to determine whether this model was superior to conventional management in improving the quality of life or asthma control in patients with severe asthma. The implementation of this project will build a new model of individualized management of severe asthma based on treatable characteristics and improve the management level of severe asthma
- Conditions
- Asthma
- Being tested
- Individualized cluster management, Routine asthma treatment
- Keywords
- treatable traits, asthma, sever, AQLQ, ACQ
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized cluster managementProcedure or surgery
Individualized cluster management for treatable traits
Routine asthma treatmentProcedure or surgery
Routine asthma treatment according to current guidelines
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Implement individualized cluster management based on treatable traits Receives: Procedure: Individualized cluster management |
| Placebo | Other | Routine asthma treatment according to current guidelines Receives: Procedure: Routine asthma treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in asthma quality of life score (AQLQ) at 6 months
Measured: 6 months
Secondary outcomes (3)
The change of asthma Control questionnaire (ACQ-5) score
Measured: At 6 months
Forced Expiratory Volume in 1 second（FEV1）
Changes in lung function Forced Expiratory Volume in 1 second（FEV1） from baseline
Measured: At 6 months
the number of asthma exacerbations within 6 months
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Feb 2025
- Primary completion31 Jan 2029 (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 AsthmaStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, The First Affiliated Hospital of Guangzhou Medical University, Shanxi Bethune Hospital, Henan Provincial People's Hospital, First Hospital of China Medical University, China-Japan Friendship Hospital, Beijing Tiantan Hospital, Second Xiangya Hospital of Central South University, Ruijin Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136025
- Sponsor's protocol ID
- 2025-KE-347
- Status last verified
- Mar 2025
- First submitted
- 18 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System
- ClinicalTrials.gov ID
- NCT07136025
- Acronym / sponsor ID
- 2025-KE-347
- Conditions
- Asthma
- Keywords
- treatable traits, asthma, sever, AQLQ, ACQ
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, The First Affiliated Hospital of Guangzhou Medical University, Shanxi Bethune Hospital, Henan Provincial People's Hospital, First Hospital of China Medical University, China-Japan Friendship Hospital, Beijing Tiantan Hospital, Second Xiangya Hospital of Central South University, Ruijin Hospital
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 22 Aug 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.
Severe asthma is a complex and heterogeneous disease. Patients with severe asthma can present with different types of airway inflammation, and are often accompanied by a variety of comorbidities and risk factors. Identification of potentially modifiable factors affecting prognosis, that is, "treatable characteristics", and individualized bundle management based on these characteristics may help to improve the quality of life of patients with asthma and improve the level of asthma control. Through joint research, this project aims to evaluate the treatable characteristics of asthma in patients with severe asthma in tertiary hospitals across the country, including lung function, fractional exhaled nitric oxide, blood routine, allergen IgE, chest CT, and a detailed questionnaire. The distribution of treatable characteristics of patients with severe asthma and its impact on the quality of life or asthma control level of patients were investigated. For patients with severe asthma, multidisciplinary consultation and shared decision-making were used to establish an individualized bundle management model based on the treatable characteristics of severe asthma. A 6-month randomized parallel controlled clinical trial was conducted to determine whether this model was superior to conventional management in improving the quality of life or asthma control in patients with severe asthma. The implementation of this project will build a new model of individualized management of severe asthma based on treatable characteristics and improve the management level of severe asthma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Individualized cluster managementImplement individualized cluster management based on treatable traits |
| Placebo | Other | Procedure: Routine asthma treatmentRoutine asthma treatment according to current guidelines |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years, and <80 years with a definite diagnosis of asthma for at least 6 months
- Patients met the 2024 GINA criteria for severe asthma, which was defined as "uncontrolled" asthma (frequent asthma symptoms, or frequent acute exacerbations) despite high-dose inhaled corticosteroids (ICS) plus long-acting β2-receptor antagonists (LABAs), or worsening of symptoms after slight tapering of high-dose therapy.
- They were willing to accept multi-disciplinary and multi-dimensional evaluation and signed informed consent
- Informed consent was obtained and patients were able to participate in the study and 6-month follow-up according to the protocol
Key exclusion criteria (11 listed)
- The presence of numerous other lung tissue destructive diseases, such as severe bronchiectasis or pulmonary tuberculosis.
- Chest surgery or abdominal surgery in the past 3 months
- Eye surgery had been performed within the past 3 months
- Myocardial infarction within the previous 3 months
- Anti-tuberculosis treatment is ongoing
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 |
|---|---|---|
| Individualized cluster managementIndividualized cluster management for treatable traits | Procedure or surgery | Intervention group |
| Routine asthma treatmentRoutine asthma treatment according to current guidelines | Procedure or surgery | Placebo |
Primary outcome
Changes from baseline in asthma quality of life score (AQLQ) at 6 months
Time frame: 6 months
3 secondary outcomes
The change of asthma Control questionnaire (ACQ-5) score
Time frame: At 6 months
Forced Expiratory Volume in 1 second（FEV1）
Time frame: At 6 months
the number of asthma exacerbations within 6 months
Time frame: within 6 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 22 Aug 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized cluster management and Routine asthma treatment in people with Asthma, run by Beijing Chao Yang Hospital at 10 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 4 inclusion and 11 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 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 Kewu Huang, professor (8613601234681, kewuhuang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in asthma quality of life score (AQLQ) at 6 months (time frame: 6 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 22 Aug 2025.