The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System
NCT ID: NCT07136025
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2025-02-01
2029-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group
Implement individualized cluster management based on treatable traits
Individualized cluster management
Individualized cluster management for treatable traits
Placebo
Routine asthma treatment according to current guidelines
Routine asthma treatment
Routine asthma treatment according to current guidelines
Interventions
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Individualized cluster management
Individualized cluster management for treatable traits
Routine asthma treatment
Routine asthma treatment according to current guidelines
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Shanxi Bethune Hospital
OTHER
Henan Provincial People's Hospital
OTHER
First Affiliated Hospital of China Medical University
UNKNOWN
China-Japan Friendship Hospital
OTHER
Beijing Tiantan Hospital
OTHER
Second Xiangya Hospital of Central South University
OTHER
Ruijin Hospital
OTHER
Beijing Chao Yang Hospital
OTHER
Responsible Party
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Locations
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Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Guangzhou Medical University
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Xiaoning Bu
Role: primary
Guochao Shi
Role: primary
Related Links
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Related Info
Other Identifiers
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2025-KE-347
Identifier Type: -
Identifier Source: org_study_id
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