The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System

NCT07136025 | Recruiting DMC

• 1 other identifier: 2025-KE-347
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

Brief 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. 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

Keywords

treatable traits; asthma; sever; AQLQ; ACQ

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in asthma quality of life score (AQLQ) at 6 months

  6 months

Secondary Outcomes (3)

• The change of asthma Control questionnaire (ACQ-5) score

  At 6 months

• Forced Expiratory Volume in 1 second（FEV1）

  At 6 months

• the number of asthma exacerbations within 6 months

  within 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Implement individualized cluster management based on treatable traits

Procedure: Individualized cluster management

Placebo

OTHER

Routine asthma treatment according to current guidelines

Procedure: Routine asthma treatment

Interventions

Individualized cluster management PROCEDURE

Individualized cluster management for treatable traits

Intervention group

Routine asthma treatment PROCEDURE

Routine asthma treatment according to current guidelines

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Shanxi Bethune Hospital: collaborator
• Henan Provincial People's Hospital: collaborator
• First Affiliated Hospital of China Medical University: collaborator
• China-Japan Friendship Hospital: collaborator
• Beijing Tiantan Hospital: collaborator
• Second Xiangya Hospital of Central South University: collaborator
• Ruijin Hospital: collaborator

Study Sites (10)

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

Beijing, Beijing Municipality, 100020, China

RECRUITING

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Shanghai, Shanghai Municipality, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Kewu Huang, professor

CONTACT

8613601234681; kewuhuang@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 22, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: August 22, 2025

Record last verified: 2025-03

Locations

CN (10)