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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2029-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Implement individualized cluster management based on treatable traits

Group Type EXPERIMENTAL

Individualized cluster management

Intervention Type PROCEDURE

Individualized cluster management for treatable traits

Placebo

Routine asthma treatment according to current guidelines

Group Type OTHER

Routine asthma treatment

Intervention Type PROCEDURE

Routine asthma treatment according to current guidelines

Interventions

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Individualized cluster management

Individualized cluster management for treatable traits

Intervention Type PROCEDURE

Routine asthma treatment

Routine asthma treatment according to current guidelines

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Shanxi Bethune Hospital

OTHER

Sponsor Role collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of China Medical University

UNKNOWN

Sponsor Role collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Site Status RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kewu Huang, professor

Role: CONTACT

8613601234681

Facility Contacts

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Kewu Huang

Role: primary

8613601234681

Xiaoning Bu

Role: primary

8613641000837

Nan Su

Role: primary

8613501157632

Qingling Zhang

Role: primary

8613609068871

Yali Guo

Role: primary

Yan Chen

Role: primary

8613508471738

Hui Shen

Role: primary

8618842320568

Guochao Shi

Role: primary

8613918462035

Lei Wang

Role: primary

8613935107849

Fen Lan

Role: primary

8615824446949

Related Links

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Other Identifiers

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2025-KE-347

Identifier Type: -

Identifier Source: org_study_id

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