Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07136025

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

Led by Beijing Chao Yang Hospital · Updated on 2025-08-22

200

Participants Needed

10

Research Sites

208 weeks

Total Duration

On this page

Sponsors

B

Beijing Chao Yang Hospital

Lead Sponsor

S

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and under 80 years with a definite asthma diagnosis for at least 6 months
  • Meet 2024 GINA criteria for severe asthma defined as uncontrolled asthma despite high-dose ICS plus LABAs or worsening symptoms after tapering
  • Willing to accept multidisciplinary evaluation and sign informed consent
  • Able to participate in the study and 6-month follow-up per protocol
Not Eligible

You will not qualify if you...

  • Having other severe lung diseases like severe bronchiectasis or pulmonary tuberculosis
  • Chest or abdominal surgery within the past 3 months
  • Eye surgery within the past 3 months
  • Myocardial infarction within the past 3 months
  • Currently receiving anti-tuberculosis treatment
  • Pregnant or breastfeeding women
  • Use of macrolides or anti-IgE, anti-IL-5, or anti-IL-5R treatments within 4 weeks before screening
  • Use of inhaled ICS+LABA+LAMA for 4 weeks before screening
  • Allergy to macrolides
  • QTc interval prolongation greater than 480ms
  • Taking medications that interact with azithromycin causing QTc prolongation or existing ECG abnormalities that may cause arrhythmia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

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

Beijing, Beijing Municipality, China, 100020

Actively Recruiting

2

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Actively Recruiting

3

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

4

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Actively Recruiting

5

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Actively Recruiting

6

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Actively Recruiting

7

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Actively Recruiting

8

The First Affiliated Hospital of Guangzhou Medical University

Shanghai, Shanghai Municipality, China

Actively Recruiting

9

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Actively Recruiting

10

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

K

Kewu Huang, professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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