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Recruiting NCT07136025

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

No phase Interventional Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Individualized cluster management, Routine asthma treatment.
Who it may be relevant to
Registry conditions: Asthma. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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 outcome measures

  • Changes from baseline in asthma quality of life score (AQLQ) at 6 months [Time frame: 6 months]
Secondary outcome measures (3)
  • The change of asthma Control questionnaire (ACQ-5) score [Time frame: At 6 months]
  • Forced Expiratory Volume in 1 second（FEV1） [Time frame: At 6 months]
  • the number of asthma exacerbations within 6 months [Time frame: within 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 10 centers
  • Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical — Beijing
  • Beijing Tiantan Hospital Affiliated to Capital Medical University — Beijing
  • China-Japan Friendship Hospital — Beijing
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • Henan Provincial People's Hospital — Zhengzhou
  • The Second Xiangya Hospital of Central South University — Changsha
  • The First Affiliated Hospital of China Medical University — Shenyang
  • The First Affiliated Hospital of Guangzhou Medical University — Shanghai
  • … and 2 more centers

Identifiers

NCT: NCT07136025 · 2025-KE-347

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗