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NCT Number: NCT07136025

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

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized cluster management

Procedure

Individualized cluster management for treatable traits

Routine asthma treatment

Procedure

Routine asthma treatment according to current guidelines

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

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

    Time frame: At 6 months

  2. Forced Expiratory Volume in 1 second（FEV1）

    Time frame: At 6 months

    Changes in lung function Forced Expiratory Volume in 1 second（FEV1） from baseline

  3. the number of asthma exacerbations within 6 months

    Time frame: within 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Kewu Huang, professor

CONTACT

[email protected]

8613601234681

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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