Recruiting

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

ClinicalTrials.gov IDNCT07136025

PhaseNA

Enrollment200

SponsorBeijing Chao Yang Hospital

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Asthma

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

Interventions

Procedure: Individualized cluster management — Individualized cluster management for treatable traits
Procedure: Routine asthma treatment — Routine asthma treatment according to current guidelines

Primary outcomes

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

Eligibility information

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

Study locations

Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University, Beijing, Beijing Municipality 100020 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

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.